PALINDROME
Report
- Report Number
- 1282497-2024-00201
- Event Type
- Death
- Date Received
- July 11, 2024
- Date of Event
- March 6, 2024
- Report Date
- September 23, 2024
- Manufacturer
- COVIDIEN LLC
- Product Code
- MSD
- UDI-DI
- 10884521157989
- PMA / PMN Number
- K123196
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL INFORMATION: B5, G3 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL INFORMATION: G3, H3, H6 H3. EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT ONE WAS OF A CLEANING WIPE, ONE WAS OF A BOX OF THE CLEANING WIPES, AND TWO WERE OF A CATHETER IN USE, BUT NOT THE PALINDROME THAT WAS DESCRIBED IN THE EVENT DESCRIPTION. IT WAS REPORTED THAT THERE WAS INGROWTH ISSUE OR CATHETER MIGRATION. THE REPORTED ISSUES COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ACCORDING TO THE REPORTER, A PATIENT WITH END-STAGE RENAL FAILURE DUE TO PROBABLE IGA NEPHROPATHY HAD HYPERTENSION. ON (B)(6) 2024, THE PATIENT'S WIFE TELEPHONED THE PERIPHERAL UNIT COMING IN TO SAY THAT THE PATIENT WAS UNWELL AND SHAKING WITH A TEMPERATURE. THE PATIENT PRESENTED TO THE PATIENT'S USUAL DIALYSIS UNIT. WHEN THE PATIENT ARRIVED, THEY CHECKED THE PATIENT'S TEMPERATURE, WHICH WAS 37.3. THEY ASKED IF THE PATIENT HAD PARACETAMOL, TO WHICH THE PATIENT REPLIED YES THREE HOURS PRIOR. THEY CHECKED THE LINE AND SAW IT WAS RED IN THE SURROUNDING AREAS UP TO HIS NECK, AND THAT LINE TUNNEL AREA WAS HOT TO TOUCH. THE CUFF APPEARED TO BE OUT AS WELL. THE DISLODGEMENT HAPPENED. THE PATIENT¿S WIFE REPORTED THAT THE PATIENT HAD A FEVER AND RIGORS. THEY CONTACTED THE RENAL REGISTRY, WHICH SAID THE PATIENT SHOULD GO TO WARD 108 AT THE MAIN HOSPITAL. AN AMBULANCE TRANSFER WAS ORGANIZED. PATIENT TRANSFERRED TO PARENT HOSPITAL WARD 108 FOR FURTHER ASSESSMENT. ON ADMISSION, PYREXIAL WITH PAIN AT THE LINE SITE WAS NOTED, AND THE DEVICE WAS REMOVED BY WARD 108 STAFF. THEY WERE UNABLE TO TELL IF IT WAS THE NURSE OR MEDICAL STAFF WHO REMOVED THE DEVICE. STARTED ON IV (INTRAVENOUS) ANTIBIOTICS VANCOMYCIN FOR SUSPECTED INFECTION. CHEST PAIN WITH ECG (ELECTROCARDIOGRAM) CHANGES AND TROPONIN RISE TO DOWN CARDIOLOGY WAS DETERMINED TO BE LIKELY RELATED TO SEPSIS OR BACKGROUND OF ESRD (END-STAGE RENAL DISEASE) AND SEVERE LVSD (LEFT VENTRICULAR SYSTOLIC DYSFUNCTION). BLOOD CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS BACTEREMIA. CRP (C-REACTIVE PROTEIN) STARTED AT 92. ON (B)(6) 2024, BLOOD CULTURES WERE POSITIVE FOR STAPH AUREUS BACTEREMIA. THE LINE WAS REPLACED WITH A TEMPORARY LINE. ON (B)(6) 2024, WHEN DIALYSIS RECOMMENCED, CRP PEAKED AT 247 AND THEN FELL BUT STAYED HIGH AT AROUND 160. THERE WERE ONGOING POSITIVE BLOOD CULTURES FOR STAPHYLOCOCCUS AUREUS ON (B)(6) 2024. ON (B)(6) 2024, THE TEMPORARY LINE WAS REMOVED. THERE WERE ONGOING POSITIVE BLOOD CULTURES FOR STAPHYLOCOCCUS AUREUS ON (B)(6) 2024. ON (B)(6) 2024, CTAP (CT DURING ARTERIAL PORTOGRAPHY) FOUND 17 X 11 MILLIMETERS OF SMALL ENHANCING COLLECTION ALONG THE RIGHT ANTERIOR ASPECT OF THE PARAVERTEBRAL SPACE AT THE LEVEL OF THE C7 VERTEBRA, EXTENDING INFERIORLY TO THE C7/T1 JUNCTION. THIS WAS AT LEAST 2 CM (CENTIMETERS) IN LENGTH; THE SUPERIOR ASPECT WAS NOT VISUALIZED IN THIS STUDY. UNDERLYING DISCITIS COULD NOT BE EXCLUDED, AND IT WAS POSSIBLY RELATED TO UNDERLYING DISKITIS. NOTE WAS ALSO MADE OF A SMALL PERIAORTIC COLLECTION ALONG THE ARCH OF THE AORTA DISTAL TO THE SUBCLAVIAN ARTERY ORIGIN, APPROXIMATELY MEASURING 3.7 CM IN LENGTH, 2.2 CM WIDE, AND 7.5 MM DEEP. THIS WAS AT THE SITE OF AN INTRAMURAL THROMBUS SEEN PREVIOUSLY. THIS MIGHT REPRESENT AN INFECTED INTRAMURAL THROMBUS. ON (B)(6) 2024, BLOOD CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS. ON THE TOE (TRANS-OESOPHAGEAL ECHOCARDIOGRAM), THERE WERE SUSPICIOUS SMALL MASSES ATTACHED TO THE AORTIC VALVE, LIKELY CONSISTENT WITH VEGETATION (NATIVE AORTIC VALVE ENDOCARDITIS). EXTRACT FROM MRI (MAGNETIC RESONANCE IMAGING) FOUND MULTILEVEL ABNORMAL SPINAL FINDINGS WHERE CERVICAL SPINE: AT C4/C5, THERE WAS EVIDENCE OF DISCITIS WITH FLUID SIGNAL IN THE DISC SPACE AND ADJACENT VERTEBRAL MARROW OEDEMA. THERE WAS AN ASSOCIATED ANTERIOR PARAVERTEBRAL COLLECTION EXTENDING FROM C4 TO T1 IN THE RIGHT PARASAGITTAL PLANE AND FROM C4 TO C6/C7 IN THE LEFT PARASAGITTAL PLANE. MODERATE CANAL STENOSIS AT C4/C5 WITH ASSOCIATED BILATERAL C5 FORAMINAL STENOSIS. THERE WAS NO EVIDENCE OF CORD EDEMA OR EPIDURAL COLLECTION. LIKELY EARLY DISCITIS AT C7/T1. WHILE IN THORACIC SPINE: MULTILEVEL DISCITIS AT T3/T4, T5/T6, T11/T12, WITH ASSOCIATED SMALL ANTERIOR EPIDURAL COLLECTION AT T5/T6. THERE WAS NO EVIDENCE OF CORD COMPRESSION OR CORD EDEMA AT THIS LEVEL. WHILE IN THE LUMBAR SPINE: MULTILEVEL DISCITIS, PREDOMINANTLY AT L3/L4, L5/S1, AND S1/S2 LEVELS. MULTILEVEL LOWER THORACIC AND LUMBAR SEVERE DISC DEGENERATION WITH ASSOCIATED FORAMINAL STENOSIS IN THE LUMBAR SPINE WAS NOTED. ON (B)(6) 2024, THE DIALYSIS LINE WAS REINSERTED. ON (B)(6) 2024, BLOOD CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS. ON (B)(6) 2024, THE DIALYSIS LINE WAS REPLACED. THE FIRST NEGATIVE CULTURE WAS NOTED, AND STAPHYLOCOCCUS AUREUS WAS ISOLATED. THE PATIENT WAS RESISTANT TO ERYTHROMYCIN, GENTAMICIN, MUPIROCIN, AND TETRACYCLINE. THE PATIENT WAS SENSITIVE TO CO-AMOXICLAV, COTRIMOXAZOLE, FLUCLOXACILLIN, FUSIDIC ACID, TEICOPLANIN, AND VANCOMYCIN. ON (B)(6) 2024, CRP ROSE AGAIN TO A HIGH OF 322, AND NO FURTHER CRP WAS CHECKED AS THE PATIENT WAS PALLIATED. IN RECOVERY POST-EXTUBATION AFTER A PROCEDURE IN THE THEATRE TO DRAIN PARASPINAL ABSCESS OR CERVICAL PARAVERTEBRAL COLLECTION SECONDARY AND RELATED TO LINE INFECTION OR SEPSIS, THE PATIENT BECAME HYPOTENSIVE AND HAD PEA (PULSELESS ELECTRICAL ACTIVITY) ARREST. THE PATIENT HAD THREE ROUNDS OF CPR (CARDIOPULMONARY RESUSCITATION) AND TWO TIMES OF ADRENALINE BEFORE ROSC (RETURN OF SPONTANEOUS CIRCULATION). REMAINED EXTUBATED, INITIALLY SIGNIFICANT NORADRENALINE REQUIREMENT, BUT WEANED ONTO METARAMINOL IN RECOVERY. ON (B)(6) 2024, POOR HEMODYNAMICS¿POST-CARDIAC ARREST, DELIRIUM, ANURIC, LOW BLOOD PRESSURE ON HIGH INOTROPIC SUPPORT, ON A 10-LITER VENTURI MASK¿AFTER SENIOR REVIEW AND DISCUSSION FOR PALLIATIVE CARE. ACTIVE TREATMENT WAS STOPPED, AND ANTICIPATORY MEDICATIONS WERE PRESCRIBED. ON (B)(6) 2024, THE PATIENT PASSED AWAY AT 07:08 WITH FAMILY PRESENT. CAUSES OF DEATH WERE IA (HEART FAILURE), IB (ACUTE MYOCARDIAL INFARCTION), IC (STAPH AUREUS BACTEREMIA), AND II (END-STAGE RENAL FAILURE) (AND ANY OTHER RELEVANT PAST MEDICAL HISTORY). THE PATIENT DIED DUE TO COMPLICATIONS FROM A LINE-RELATED INFECTION. DEATH IS REFERRED TO PF (PROCURATOR FISCAL). PF WAS HAPPY FOR MEDICAL STAFF TO ISSUE A DEATH CERTIFICATE DUE TO PATIENT FRAILTY, EXISTING RENAL ISSUES, AND INFECTION. STANDARD CLEANING OF DIALYSIS CATHETER IN THE UNIT WITH GREEN CLINELL DEVICE WIPES, 2% CHLORHEXIDINE, 70% ALCOHOL, AND BD CHLORAPREP ON DRESSING CHANGE DAYS. STANDARD RENAL PANELS INCLUDED UREA AND ELECTROLYTES, LIVER FUNCTION TESTS, BONE PROFILE, BICARBONATE, CRP, AND A FULL BLOOD COUNT AS LAB OR BLOODWORK TESTS; THEY WERE DONE DAILY DURING ADMISSION. THERE WAS SOME CONFUSION AROUND WHETHER THE INFECTION WAS METHICILLIN-RESISTANT STAPH (MRSA) OR METHICILLIN-SUSCEPTIBLE STAPH (MSSA), BUT IT WAS DEEMED TO BE MSSA IN THE END. ANTIBIOTIC TREATMENT INCLUDED GENTAMYCIN, VANCOMYCIN, AND FLUCLOXACILLIN, ALL ANTIBIOTIC TREATMENTS GIVEN UNDER THE GUIDANCE OF MICROBIOLOGY. THE PATIENT REQUIRED A 3-WEEK-LONG HOSPITAL ADMISSION, THREE TEMPORARY JUGULAR DIALYSIS LINES (ON WHICH THEY WERE ABLE TO PROCEED AND COMPLETE TREATMENT), IV ANTIBIOTICS, A CT (COMPUTED TOMOGRAPHY) SCAN, AN MRI SCAN, A THEATER FOR PARASPINAL ABSCESS DRAINAGE, RESUSCITATION, AND AN HDU (HIGH DEPENDENCY UNIT) STAY DUE TO THE METARAMINOL REQUIREMENT AS THE INTERVENTIONS AND TREATMENTS REQUIRED AS A RESULT OF THE EVENT.
ACCORDING TO THE REPORTER, A PATIENT WITH END-STAGE RENAL FAILURE DUE TO PROBABLE IGA NEPHROPATHY HAD HYPERTENSION. ON (B)(6) 2024, THE PATIENT'S WIFE TELEPHONED THE PERIPHERAL UNIT COMING IN TO SAY THAT THE PATIENT WAS UNWELL AND SHAKING WITH A TEMPERATURE. THE PATIENT PRESENTED TO THE PATIENT'S USUAL DIALYSIS UNIT. WHEN THE PATIENT ARRIVED, THEY CHECKED THE PATIENT'S TEMPERATURE, WHICH WAS 37.3. THEY ASKED IF THE PATIENT HAD PARACETAMOL, TO WHICH THE PATIENT REPLIED YES THREE HOURS PRIOR. THEY CHECKED THE LINE AND SAW IT WAS RED IN THE SURROUNDING AREAS UP TO HIS NECK, AND THAT LINE TUNNEL AREA WAS HOT TO TOUCH. THE CUFF APPEARED TO BE OUT AS WELL. THE DISLODGEMENT HAPPENED. THE PATIENT¿S WIFE REPORTED THAT THE PATIENT HAD A FEVER AND RIGORS. THEY CONTACTED THE RENAL REGISTRY, WHICH SAID THE PATIENT SHOULD GO TO WARD 108 AT THE MAIN HOSPITAL. AN AMBULANCE TRANSFER WAS ORGANIZED. PATIENT TRANSFERRED TO PARENT HOSPITAL WARD 108 FOR FURTHER ASSESSMENT. ON ADMISSION, PYREXIAL WITH PAIN AT THE LINE SITE WAS NOTED, AND THE DEVICE WAS REMOVED BY WARD 108 STAFF. THEY WERE UNABLE TO TELL IF IT WAS THE NURSE OR MEDICAL STAFF WHO REMOVED THE DEVICE. STARTED ON IV (INTRAVENOUS) ANTIBIOTICS VANCOMYCIN FOR SUSPECTED INFECTION. CHEST PAIN WITH ECG (ELECTROCARDIOGRAM) CHANGES AND TROPONIN RISE TO DOWN CARDIOLOGY WAS DETERMINED TO BE LIKELY RELATED TO SEPSIS OR BACKGROUND OF ESRD (END-STAGE RENAL DISEASE) AND SEVERE LVSD (LEFT VENTRICULAR SYSTOLIC DYSFUNCTION). BLOOD CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS BACTEREMIA. CRP (C-REACTIVE PROTEIN) STARTED AT 92. ON (B)(6) 2024, BLOOD CULTURES WERE POSITIVE FOR STAPH AUREUS BACTEREMIA. THE LINE WAS REPLACED WITH A TEMPORARY LINE. ON (B)(6) 2024, WHEN DIALYSIS RECOMMENCED, CRP PEAKED AT 247 AND THEN FELL BUT STAYED HIGH AT AROUND 160. THERE WERE ONGOING POSITIVE BLOOD CULTURES FOR STAPHYLOCOCCUS AUREUS ON MARCH (B)(6) 2024. ON (B)(6) 2024, THE TEMPORARY LINE WAS REMOVED. THERE WERE ONGOING POSITIVE BLOOD CULTURES FOR STAPHYLOCOCCUS AUREUS ON MARCH (B)(6) 2024. ON (B)(6) 2024, CTAP (CT DURING ARTERIAL PORTOGRAPHY) FOUND 17 X 11 MILLIMETERS OF SMALL ENHANCING COLLECTION ALONG THE RIGHT ANTERIOR ASPECT OF THE PARAVERTEBRAL SPACE AT THE LEVEL OF THE C7 VERTEBRA, EXTENDING INFERIORLY TO THE C7/T1 JUNCTION. THIS WAS AT LEAST 2 CM (CENTIMETERS) IN LENGTH; THE SUPERIOR ASPECT WAS NOT VISUALIZED IN THIS STUDY. UNDERLYING DISCITIS COULD NOT BE EXCLUDED, AND IT WAS POSSIBLY RELATED TO UNDERLYING DISKITIS. NOTE WAS ALSO MADE OF A SMALL PERIAORTIC COLLECTION ALONG THE ARCH OF THE AORTA DISTAL TO THE SUBCLAVIAN ARTERY ORIGIN, APPROXIMATELY MEASURING 3.7 CM IN LENGTH, 2.2 CM WIDE, AND 7.5 MM DEEP. THIS WAS AT THE SITE OF AN INTRAMURAL THROMBUS SEEN PREVIOUSLY. THIS MIGHT REPRESENT AN INFECTED INTRAMURAL THROMBUS. ON (B)(6) 2024, BLOOD CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS. ON THE TOE (TRANS-OESOPHAGEAL ECHOCARDIOGRAM), THERE WERE SUSPICIOUS SMALL MASSES ATTACHED TO THE AORTIC VALVE, LIKELY CONSISTENT WITH VEGETATION (NATIVE AORTIC VALVE ENDOCARDITIS). EXTRACT FROM MRI (MAGNETIC RESONANCE IMAGING) FOUND MULTILEVEL ABNORMAL SPINAL FINDINGS WHERE CERVICAL SPINE: AT C4/C5, THERE WAS EVIDENCE OF DISCITIS WITH FLUID SIGNAL IN THE DISC SPACE AND ADJACENT VERTEBRAL MARROW OEDEMA. THERE WAS AN ASSOCIATED ANTERIOR PARAVERTEBRAL COLLECTION EXTENDING FROM C4 TO T1 IN THE RIGHT PARASAGITTAL PLANE AND FROM C4 TO C6/C7 IN THE LEFT PARASAGITTAL PLANE. MODERATE CANAL STENOSIS AT C4/C5 WITH ASSOCIATED BILATERAL C5 FORAMINAL STENOSIS. THERE WAS NO EVIDENCE OF CORD EDEMA OR EPIDURAL COLLECTION. LIKELY EARLY DISCITIS AT C7/T1. WHILE IN THORACIC SPINE: MULTILEVEL DISCITIS AT T3/T4, T5/T6, T11/T12, WITH ASSOCIATED SMALL ANTERIOR EPIDURAL COLLECTION AT T5/T6. THERE WAS NO EVIDENCE OF CORD COMPRESSION OR CORD EDEMA AT THIS LEVEL. WHILE IN THE LUMBAR SPINE: MULTILEVEL DISCITIS, PREDOMINANTLY AT L3/L4, L5/S1, AND S1/S2 LEVELS. MULTILEVEL LOWER THORACIC AND LUMBAR SEVERE DISC DEGENERATION WITH ASSOCIATED FORAMINAL STENOSIS IN THE LUMBAR SPINE WAS NOTED. ON (B)(6) 2024, THE DIALYSIS LINE WAS REINSERTED. ON (B)(6) 2024, BLOOD CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS. ON (B)(6) 2024, THE DIALYSIS LINE WAS REPLACED. THE FIRST NEGATIVE CULTURE WAS NOTED, AND STAPHYLOCOCCUS AUREUS WAS ISOLATED. THE PATIENT WAS RESISTANT TO ERYTHROMYCIN, GENTAMICIN, MUPIROCIN, AND TETRACYCLINE. THE PATIENT WAS SENSITIVE TO CO-AMOXICLAV, COTRIMOXAZOLE, FLUCLOXACILLIN, FUSIDIC ACID, TEICOPLANIN, AND VANCOMYCIN. ON (B)(6) 2024, CRP ROSE AGAIN TO A HIGH OF 322, AND NO FURTHER CRP WAS CHECKED AS THE PATIENT WAS PALLIATED. IN RECOVERY POST-EXTUBATION AFTER A PROCEDURE IN THE THEATRE TO DRAIN PARASPINAL ABSCESS OR CERVICAL PARAVERTEBRAL COLLECTION SECONDARY AND RELATED TO LINE INFECTION OR SEPSIS, THE PATIENT BECAME HYPOTENSIVE AND HAD PEA (PULSELESS ELECTRICAL ACTIVITY) ARREST. THE PATIENT HAD THREE ROUNDS OF CPR (CARDIOPULMONARY RESUSCITATION) AND TWO TIMES OF ADRENALINE BEFORE ROSC (RETURN OF SPONTANEOUS CIRCULATION). REMAINED EXTUBATED, INITIALLY SIGNIFICANT NORADRENALINE REQUIREMENT, BUT WEANED ONTO METARAMINOL IN RECOVERY. ON (B)(6) 2024, POOR HEMODYNAMICS¿POST-CARDIAC ARREST, DELIRIUM, ANURIC, LOW BLOOD PRESSURE ON HIGH INOTROPIC SUPPORT, ON A 10-LITER VENTURI MASK¿AFTER SENIOR REVIEW AND DISCUSSION FOR PALLIATIVE CARE. ACTIVE TREATMENT WAS STOPPED, AND ANTICIPATORY MEDICATIONS WERE PRESCRIBED. ON (B)(6) 2024, THE PATIENT PASSED AWAY AT 07:08 WITH FAMILY PRESENT. CAUSES OF DEATH WERE IA (HEART FAILURE), IB (ACUTE MYOCARDIAL INFARCTION), IC (STAPH AUREUS BACTEREMIA), AND II (END-STAGE RENAL FAILURE) (AND ANY OTHER RELEVANT PAST MEDICAL HISTORY). THE PATIENT DIED DUE TO COMPLICATIONS FROM A LINE-RELATED INFECTION. DEATH IS REFERRED TO PF (PROCURATOR FISCAL). PF WAS HAPPY FOR MEDICAL STAFF TO ISSUE A DEATH CERTIFICATE DUE TO PATIENT FRAILTY, EXISTING RENAL ISSUES, AND INFECTION. STANDARD CLEANING OF DIALYSIS CATHETER IN THE UNIT WITH GREEN CLINELL DEVICE WIPES, 2% CHLORHEXIDINE, 70% ALCOHOL, AND BD CHLORAPREP ON DRESSING CHANGE DAYS. THEY WERE UNSURE OF THE EXACT DATE THEY STARTED USING CLINELL WIPES AS STANDARD CLEANING FOR DIALYSIS CAT HETERS, BUT THEY HAD BEEN USING THEM FOR AT LEAST 7 OR 8 YEARS. THE CONTENTS AND COMPONENTS OF THE WIPES WERE 2% CHLORHEXIDINE AND 70% ALCOHOL. THE SCRUB USED THE HUB PROTOCOL. THE ENDS OF THE DIALYSIS CATHETER WERE UNWRAPPED FROM THEIR GAUZE AND PLACED ON A STERILE FIELD. THE NURSE PERFORMED HAND HYGIENE AND WOULD DON STERILE GLOVES BEFORE USING THE WIPES TO CLEAN THE DEADENDERS AND THE WHOLE OF EACH LUMEN (INCLUDING THE CLAMPS) UP TO THE EDGE OF THE DRESSING. ONE WIPE WAS USED PER LUMEN, AND THEY WERE CLEANED SIMULTANEOUSLY. NO REAL TUGGING OR FORCEFUL PULLING OF THE LINE OCCURRED DURING THE CLEANING PROCESS. THE CLEAN LUMENS WERE THEN PLACED ON STERILE GAUZE SWABS BEFORE THE NURSE ASPIRATED AND FLUSHED THE LINE. THEY USED CHLORHEXADINE BIOPATCH DRESSINGS THAT WERE CHANGED WEEKLY. ON DRESSING CHANGE DAYS, THE DRESSING WAS REMOVED, AND THE ENTIRE AREA, INCLUDING THE ENTRY SITE, WAS CLEANED WITH CHLORAPREP. IF THE PATIENT WAS UNABLE TO TOLERATE CLEANING WITH CHLORHEXIDINE DUE TO SKIN SENSITIVITY, THEY USED STERILE GAUZE SWABS SOAKED WITH A 10% PROVIDONE IODINE SOLUTION IN PLACE OF THE CLINELL WIPES AND CHLORAPREP. STANDARD RENAL PANELS INCLUDED UREA AND ELECTROLYTES, LIVER FUNCTION TESTS, BONE PROFILE, BICARBONATE, CRP, AND A FULL BLOOD COUNT AS LAB OR BLOODWORK TESTS; THEY WERE DONE DAILY DURING ADMISSION. THERE WAS SOME CONFUSION AROUND WHETHER THE INFECTION WAS METHICILLIN-RESISTANT STAPH (MRSA) OR METHICILLIN-SUSCEPTIBLE STAPH (MSSA), BUT IT WAS DEEMED TO BE MSSA IN THE END. ANTIBIOTIC TREATMENT INCLUDED GENTAMYCIN, VANCOMYCIN, AND FLUCLOXACILLIN, ALL ANTIBIOTIC TREATMENTS GIVEN UNDER THE GUIDANCE OF MICROBIOLOGY. THE PATIENT REQUIRED A 3-WEEK-LONG HOSPITAL ADMISSION, THREE TEMPORARY JUGULARDIALYSIS LINES (ON WHICH THEY WERE ABLE TO PROCEED AND COMPLETE TREATMENT), IV ANTIBIOTICS, A CT (COMPUTED TOMOGRAPHY) SCAN, AN MRI SCAN, A THEATER FOR PARASPINAL ABSCESS DRAINAGE, RESUSCITATION, AND AN HDU (HIGH DEPENDENCY UNIT) STAY DUE TO THE METARAMINOL REQUIREMENT AS THE INTERVENTIONS AND TREATMENTS REQUIRED AS A RESULT OF THE EVENT.
ACCORDING TO THE REPORTER, A PATIENT WITH END-STAGE RENAL FAILURE DUE TO PROBABLE IGA NEPHROPATHY HAD HYPERTENSION. ON (B)(6) 2024, THE PATIENT'S WIFE TELEPHONED THE PERIPHERAL UNIT COMING IN TO SAY THAT THE PATIENT WAS UNWELL AND SHAKING WITH A TEMPERATURE. THE PATIENT PRESENTED TO THE PATIENT'S USUAL DIALYSIS UNIT. WHEN THE PATIENT ARRIVED, THEY CHECKED THE PATIENT'S TEMPERATURE, WHICH WAS 37.3. THEY ASKED IF THE PATIENT HAD PARACETAMOL, TO WHICH THE PATIENT REPLIED YES THREE HOURS PRIOR. THEY CHECKED THE LINE AND SAW IT WAS RED IN THE SURROUNDING AREAS UP TO HIS NECK, AND THAT LINE TUNNEL AREA WAS HOT TO TOUCH. THE CUFF APPEARED TO BE OUT AS WELL. THE DISLODGEMENT HAPPENED. THE PATIENT¿S WIFE REPORTED THAT THE PATIENT HAD A FEVER AND RIGORS. THEY CONTACTED THE RENAL REGISTRAR, WHICH SAID THE PATIENT SHOULD GO TO WARD 108 AT THE MAIN HOSPITAL. AN AMBULANCE TRANSFER WAS ORGANIZED. PATIENT TRANSFERRED TO PARENT HOSPITAL WARD 108 FOR FURTHER ASSESSMENT. ON ADMISSION, PYREXIAL WITH PAIN AT THE LINE SITE WAS NOTED, AND THE DEVICE WAS REMOVE D BY WARD 108 STAFF. THEY WERE UNABLE TO TELL IF IT WAS THE NURSE OR MEDICAL STAFF WHO REMOVED THE DEVICE. STARTED ON IV (INTRAVENOUS) ANTIBIOTICS VANCOMYCIN FOR SUSPECTED INFECTION. CHEST PAIN WITH ECG (ELECTROCARDIOGRAM) CHANGES AND TROPONIN RISE TO DOWN CARDIOL OGY WAS DETERMINED TO BE LIKELY RELATED TO SEPSIS OR BACKGROUND OF ESRD (END-STAGE RENAL DISEASE) AND SEVERE LVSD (LEFT VENTRICULAR SYSTOLIC DYSFUNCTION). BLOOD CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS BACTEREMIA. CRP (C-REACTIVE PROTEIN) STARTED AT 92. ON (B)(6) 2024, BLOOD CULTURES WERE POSITIVE FOR STAPH AUREUS BACTEREMIA. THE LINE WAS REPLACED WITH A TEMPORARY LINE. ON (B)(6) 2024, WHEN DIALYSIS RECOMMENCED, CRP PEAKED AT 247 AND THEN FELL BUT STAYED HIGH AT AROUND 160. THERE WERE ONGOING POSITIVE BLOOD CULTURES FOR STAPHYLOCOCCUS AUREUS ON (B)(6) 2024. ON (B)(6) 2024, THE TEMPORARY LINE WAS REMOVED. THERE WERE ONGOING POSITIVE BLOOD CULTURES FOR STAPHYLOCOCCUS AUREUS ON (B)(6) 2024. ON (B)(6) 2024, CTAP (CT DURING ARTERIAL PORTOGRAPHY) FOUND 17 X 11 MILLIMETERS OF SMALL ENHANCING COLLECTION ALONG THE RIGHT ANTERIOR ASPECT OF THE PARAVERTEBRAL SPACE AT THE LEVEL OF THE C7 VERTEBRA, EXTENDING INFERIORLY TO THE C7/T1 JUNCTION. THIS WAS AT LEAST 2 CM (CENTIMETERS) IN LENGTH; THE SUPERIOR ASPECT WAS NOT VISUALIZED IN THIS STUDY. UNDERLYING DISCITIS COULD NOT BE EXCLUDED, AND IT WAS POSSIBLY RELATED TO UNDERLYING DISKITIS. NOTE WAS ALSO MADE OF A SMALL PERIAORTIC COLLECTION ALONG THE ARCH OF THE AORTA DISTAL TO THE SUBCLAVIAN ARTERY ORIGIN, APPROXIMATELY MEASURING 3.7 CM IN LENGTH, 2.2 CM WIDE, AND 7.5 MM DEEP. THIS WAS AT THE SITE OF AN INTRAMURAL THROMBUS SEEN PREVIOUSLY. THIS MIGHT REPRESENT AN INFECTED INTRAMURAL THROMBUS. ON (B)(6) 2024, BLOOD CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS. ON THE TOE (TRANS-OESOPHAGEAL ECHOCARDIOGRAM), THERE WERE SUSPICIOUS SMALL MASSES ATTACHED TO THE AORTIC VALVE, LIKELY CONSISTENT WITH VEGETATION (NATIVE AORTIC VALVE ENDOCARDITIS). EXTRACT FROM MRI (MAGNETIC RESONANCE IMAGING) FOUND MULTILEVEL ABNORMAL SPINAL FINDINGS WHERE CERVICAL SPINE: AT C4/C5, THERE WAS EVIDENCE OF DISCITIS WITH FLUID SIGNAL IN THE DISC SPACE AND ADJACENT VERTEBRAL MARROW OEDEMA. THERE WAS AN ASSOCIATED ANTERIOR PARAVERTEBRAL COLLECTION EXTENDING FROM C4 TO T1 IN THE RIGHT PARASAGITTAL PLANE AND FROM C4 TO C6/C7 IN THE LEFT PARASAGITTAL PLANE. MODERATE CANAL STENOSIS AT C4/C5 WITH ASSOCIATED BILATERAL C5 FORAMINAL STENOSIS. THERE WAS NO EVIDENCE OF CORD EDEMA OR EPIDURAL COLLECTION. LIKELY EARLY DISCITIS AT C7/T1. WHILE IN THORACIC SPINE: MULTILEVEL DISCITIS AT T3/T4, T5/T6, T11/T12, WITH ASSOCIATED SMALL ANTERIOR EPIDURAL COLLECTION AT T5/T6. THERE WAS NO EVIDENCE OF CORD COMPRESSION OR CORD EDEMA AT THIS LEVEL. WHILE IN THE LUMBAR SPINE: MULTILEVEL DISCITIS, PREDOMINANTLY AT L3/L4, L5/S1, AND S1/S2 LEVELS. MULTILEVEL LOWER THORACIC AND LUMBAR SEVERE DISC DEGENERATION WITH ASSOCIATED FORAMINAL STENOSIS IN THE LUMBAR SPINE WAS NOTED. ON (B)(6) 2024, THE DIALYSIS LINE WAS REINSERTED. ON (B)(6) 2024, BLOOD CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS. ON (B)(6) 2024, THE DIALYSIS LINE WAS REPLACED. THE FIRST NEGATIVE CULTURE WAS NOTED, AND STAPHYLOCOCCUS AUREUS WAS ISOLATED. THE PATIENT WAS RESISTANT TO ERYTHROMYCIN, GENTAMICIN, MUPIROCIN, AND TETRACYCLINE. THE PATIENT WAS SENSITIVE TO CO-AMOXICLAV, COTRIMOXAZOLE, FLUCLOXACILLIN, FUSIDIC ACID, TEICOPLANIN, AND VANCOMYCIN. ON (B)(6) 2024, CRP ROSE AGAIN TO A HIGH OF 322, AND NO FURTHER CRP WAS CHECKED AS THE PATIENT WAS PALLIATED. IN RECOVERY POST-EXTUBATION AFTER A PROCEDURE IN THE THEATRE TO DRAIN PARASPINAL ABSCESS OR CERVICAL PARAVERTEBRAL COLLECTION SECONDARY AND RELATED TO LINE INFECTION OR SEPSIS, THE PATIENT BECAME HYPOTENSIVE AND HAD PEA (PULSELESS ELECTRICAL ACTIVITY) ARREST. THE PATIENT HAD THREE ROUNDS OF CPR (CARDIOPULMONARY RESUSCITATION) AND TWO TIMES OF ADRENALINE BEFORE ROSC (RETURN OF SPONTANEOUS CIRCULATION). REMAINED EXTUBATED, INITIALLY SIGNIFICANT NORADRENALINE REQUIREMENT, BUT WEANED ONTO METARAMINOL IN RECOVERY. ON (B)(6) 2024, POOR HEMODYNAMICS¿POST-CARDIAC ARREST, DELIRIUM, ANURIC, LOW BLOOD PRESSURE ON HIGH INOTROPIC SUPPORT, ON A 10-LITER VENTURI MASK¿AFTER SENIOR REVIEW AND DISCUSSION FOR PALLIATIVE CARE. ACTIVE TREATMENT WAS STOPPED, AND ANTICIPATORY MEDICATIONS WERE PRESCRIBED. ON (B)(6) 2024, THE PATIENT PASSED AWAY AT 07:08 WITH FAMILY PRESENT. CAUSES OF DEATH WERE IA (HEART FAILURE), IB (ACUTE MYOCARDIAL INFARCTION), IC (STAPH AUREUS BACTEREMIA), AND II (END-STAGE RENAL FAILURE) (AND ANY OTHER RELEVANT PAST MEDICAL HISTORY). THE PATIENT DIED DUE TO COMPLICATIONS FROM A LINE-RELATED INFECTION. DEATH IS REFERRED TO PF (PROCURATOR FISCAL). PF WAS HAPPY FOR MEDICAL STAFF TO ISSUE A DEATH CERTIFICATE DUE TO PATIENT FRAILTY, EXISTING RENAL ISSUES, AND INFECTION. THE CATHETER WAS IN PLACE FOR 34 DAYS. STANDARD CLEANING OF DIALYSIS CATHETER IN THE UNIT WITH GREEN CLINELL DEVICE WIPES, 2% CHLORHEXIDINE, 70% ALCOHOL, AND BD CHLORAPREP ON DRESSING CHANGE DAYS. THEY WERE UNSURE OF THE EXACT DATE THEY STARTED USING CLINELL WIPES AS STANDARD CLEANING FOR DIALYSIS CATHETERS, BUT THEY HAD BEEN USING THEM FOR AT LEAST 7 OR 8 YEARS. THE CONTENTS AND COMPONENTS OF THE WIPES WERE 2% CHLORHEXIDINE AND 70% ALCOHOL. THE SCRUB USED THE HUB PROTOCOL. THE ENDS OF THE DIALYSIS CATHETER WERE UNWRAPPED FROM THEIR GAUZE AND PLACED ON A STERILE FIELD. THE NURSE PERFORMED HAND HYGIENE AND WOULD DON STERILE GLOVES BEFORE USING THE WIPES TO CLEAN THE DEADENDERS AND THE WHOLE OF EACH LUMEN (INCLUDING THE CLAMPS) UP TO THE EDGE OF THE DRESSING. ONE WIPE WAS USED PER LUMEN, AND THEY WERE CLEANED SIMULTANEOUSLY. NO REAL TUGGING OR FORCEFUL PULLING OF THE LINE OCCURRED DURING THE CLEANING PROCESS. THE CLEAN LUMENS WERE THEN PLACED ON STERILE GAUZE SWABS BEFORE THE NURSE ASPIRATED AND FLUSHED THE LINE. THEY USED CHLORHEXIDINE BIOPATCH DRESSINGS THAT WERE CHANGED WEEKLY. ON DRESSING CHANGE DAYS, THE DRESSING WAS REMOVED, AND THE ENTIRE AREA, INCLUDING THE ENTRY SITE, WAS CLEANED WITH CHLORAPREP. IF THE PATIENT WAS UNABLE TO TOLERATE CLEANING WITH CHLORHEXIDINE DUE TO SKIN SENSITIVITY, THEY USED STERILE GAUZE SWABS SOAKED WITH A 10% POVIDONE IODINE SOLUTION IN PLACE OF THE CLINELL WIPES AND CHLORAPREP. STANDARD RENAL PANELS INCLUDED UREA AND ELECTROLYTES, LIVER FUNCTION TESTS, BONE PROFILE, BICARBONATE, CRP, AND A FULL BLOOD COUNT AS LAB OR BLOODWORK TESTS; THEY WERE DONE DAILY DURING ADMISSION. THERE WAS SOME CONFUSION AROUND WHETHER THE INFECTION WAS METHICILLIN-RESISTANT STAPH (MRSA) OR METHICILLIN-SUSCEPTIBLE STAPH (MSSA), BUT IT WAS DEEMED TO BE MSSA IN THE END. ANTIBIOTIC TREATMENT INCLUDED GENTAMYCIN, VANCOMYCIN, AND FLUCLOXACILLIN, ALL ANTIBIOTIC TREATMENTS GIVEN UNDER THE GUIDANCE OF MICROBIOLOGY. THE PATIENT REQUIRED A 3-WEEK-LONG HOSPITAL ADMISSION, THREE TEMPORARY JUGULAR DIALYSIS LINES (ON WHICH THEY WERE ABLE TO PROCEED AND COMPLETE TREATMENT), IV ANTIBIOTICS, A CT (COMPUTED TOMOGRAPHY) SCAN, AN MRI SCAN, A THEATER FOR PARASPINAL ABSCESS DRAINAGE, RESUSCITATION, AND AN HDU (HIGH DEPENDENCY UNIT) STAY DUE TO THE METARAMINOL REQUIREMENT AS THE INTERVENTIONS AND TREATMENTS REQUIRED AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2386052 | PALINDROME | CATHETER, HEMODIALYSIS, IMPLANTED | MSD | COVIDIEN LLC | 8888145015P | 2314400175 | 10884521157989 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Male | Hospitalization| R| O| D |