PALINDROME
Report
- Report Number
- 1282497-2024-00238
- Event Type
- Injury
- Date Received
- July 24, 2024
- Date of Event
- June 29, 2024
- Report Date
- October 3, 2024
- Manufacturer
- COVIDIEN LLC
- Product Code
- MSD
- UDI-DI
- 20884521013169
- PMA / PMN Number
- K111372
- 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. 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: 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 AVAILABLE FOR EVALUATION. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THE SAMPLE MET ALL RELATED SPECIFICATIONS. IT WAS REPORTED THAT THERE WAS AN INGROWTH OR CATHETER MIGRATION ISSUE. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. 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.
ACCORDING TO THE REPORTER, THE PATIENT ATTENDED THE UNIT FOR THE USUAL DIALYSIS SESSION. AN HOUR AND FORTY-FIVE MINUTES INTO DIALYSIS, THE PATIENT HAD AN EPISODE OF VOMITING AND NEEDED TO USE THE COMMODE. WHEN THE NURSE WENT TO ASSIST THE PATIENT BACK TO THE CHAIR, THE NURSE NOTICED THE LINE WAS SIGNIFICANTLY OUT AND THE PRESSURES ON THE MACHINE WERE HIGH. THE PATIENT MAY HAVE TUGGED ON LINES WHILE TRANSFERRING, BUT THE PATIENT SAID IT DID NOT APPLY SIGNIFICANT OR SHARP FORCE. THE PATIENT FELT NOTHING AS THE LINE CAME OUT AND SAID IT JUST SLID OUT WITH NO TUGGING OR PULLING SENSATION. STITCHES HAD ONLY BEEN REMOVED AT THE START OF THIS DIALYSIS SESSION. UNABLE TO WASH BACK AS THE CIRCUIT CLOTTED. AS THE REMEDIAL ACTION WAS PERFORMED, THE LINE WAS SECURED WITH EXTRA DRESSINGS. THERE WAS NO UNUSUAL ACTIVITY OBSERVED ON THE DEVICE PRIOR TO USE, ONLY SOME REDNESS THAT HAD BEEN REPORTED AROUND THE ENTRY SITE PREVIOUSLY. SWABS WERE NEGATIVE. THE LINE GETS DRESSED WITH GAUZE, INADINE, AND MEPORE DUE TO PREVIOUS DRESSING INFECTIONS. THE LINE HAD W ORKED FINE FOR DIALYSIS, ONCE DISPLACED, THE LINE WAS TOO FAR OUT TO ATTEMPT TO USE IT AGAIN. THE PATIENT WAS TRANSFERRED TO THE ABERDEEN ROYAL INFIRMARY FOR FURTHER ASSESSMENT. THE X-RAY SHOWED THE LINE TIP WAS NEAR THE ENTRY TO THE JUGULAR VEIN, POSSIBLY STILL IN THE VEIN, POSSIBLY IN THE TUNNEL. THE LINE WAS REMOVED. THE CONSULTANT ON CALL FOR THIS WEEKEND THOUGHT THIS LINE SHOULD BE REPORTED ALONG WITH ALL THE OTHER CUFF DISPLACEMENTS AS IT APPEARS THAT THE CUFF HAD NOT EVEN STARTED TO IMPLANT, WHICH IS UNUSUAL GIVEN IT HAD BEEN IN FOR MORE THAN A MONTH. THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE WAS GREEN CLINELL DEVICE WIPES, 2% CHLORHEXIDINE, 70% ALCOHOL, AND BD CHLORAPREP ON DRESSING CHANGE DAYS. THE INTERVENTION OR TREATMENT REQUIRED WAS TO BE ADMITTED TO THE HOSPITAL FOR FURTHER ASSESSMENT OR A NEW LINE. THERE WAS A BLOOD LOSS OF 400 ML, AND A BLOOD TRANSFUSION WAS NOT REQUIRED. IT WAS STATED ON THE REPORT THAT THE PATIENT HAD CURRENT AND PRE-EXISTING CONDITION THAT MAY BE RELATED TO EVENT SUCH AS TYPE 1 DIABETES, OBESITY, OVERNIGHT NIV DUE TO OBESITY HYPOVENTILATION SYNDROME, END STAGE RENAL FAILURE PROBABLY DUE TO DIABETIC NEPHROPATHY, RECENT START ON HAEMODIALYSIS- (B)(6) 2023, ATTEMPTED TO START DIALYSIS VIA AVF BUT SUFFERED FREQUENT BLOWS WHEN NEEDLING AND VERY POOR FLOWS EVEN IF CANNULATION SUCCESSFUL, FISTULA CLOTTED OFF AT START OF (B)(6) 2024. PATIENT HAD DISLODGEMENT OF PREVIOUS LINE CUFF (B)(6) 2024.
ACCORDING TO THE REPORTER, THE PATIENT ATTENDED THE UNIT FOR THE USUAL DIALYSIS SESSION. AN HOUR AND FORTY-FIVE MINUTES INTO DIALYSIS, THE PATIENT HAD AN EPISODE OF VOMITING AND NEEDED TO USE THE COMMODE. WHEN THE NURSE WENT TO ASSIST THE PATIENT BACK TO THE CHAIR, THE NURSE NOTICED THE LINE WAS SIGNIFICANTLY OUT AND THE PRESSURES ON THE MACHINE WERE HIGH. THE PATIENT MAY HAVE TUGGED ON LINES WHILE TRANSFERRING, BUT THE PATIENT SAID IT DID NOT APPLY SIGNIFICANT OR SHARP FORCE. THE PATIENT FELT NOTHING AS THE LINE CAME OUT (MEANING THE LINE WAS DISPLACED) AND SAID IT JUST SLID OUT WITH NO TUGGING OR PULLING SENSATION. THE PATIENT DID NOT NOTICE ANY SNAGGING OR PULLING. THE PATIENT SAID THE LINES MAY HAVE BEEN TUGGED A LITTLE WHILE TRANSFERRING BUT NOT WITH ANY SIGNIFICANT FORCE. STITCHES HAD ONLY BEEN REMOVED AT THE START OF THIS DIALYSIS SESSION, SO IT WAS HELD IN PLACE WITH DRESSINGS, BUT IT SHOULD HAVE STARTED TO IMPLANT GIVEN THAT IT HAD BEEN IN FOR MORE THAN A MONTH. UNABLE TO WASH BACK AS THE CIRCUIT CLOTTED. AS THE REMEDIAL ACTION WAS PERFORMED, THE LINE WAS SECURED WITH EXTRA DRESSINGS. THERE WAS NO UNUSUAL ACTIVITY OBSERVED ON THE DEVICE PRIOR TO USE, ONLY SOME REDNESS THAT HAD BEEN REPORTED AROUND THE ENTRY SITE PREVIOUSLY. SWABS WERE NEGATIVE. THE LINE GETS DRESSED WITH GAUZE, INADINE, AND MEPORE DUE TO PREVIOUS DRESSING INFECTIONS. THE LINE HAD WORKED FINE FOR DIALYSIS; ONCE DISPLACED, THE LINE WAS TOO FAR OUT TO ATTEMPT TO USE IT AGAIN. THE PATIENT WAS TRANSFERRED TO THE ABERDEEN ROYAL INFIRMARY FOR FURTHER ASSESSMENT. THE X-RAY SHOWED THE LINE TIP WAS NEAR THE ENTRY TO THE JUGULAR VEIN, POSSIBLY STILL IN THE VEIN, POSSIBLY IN THE TUNNEL. THE LINE WAS REMOVED. THE CONSULTANT ON CALL FOR THIS WEEKEND THOUGHT THIS LINE SHOULD BE REPORTED ALONG WITH ALL THE OTHER CUFF DISPLACEMENTS AS IT APPEARS THAT THE CUFF HAD NOT EVEN STARTED TO IMPLANT, WHICH IS UNUSUAL GIVEN IT HAD BEEN IN FOR MORE THAN A MONTH. THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE WAS GREEN CLINELL DEVICE WIPES, 2% CHLORHEXIDINE, 70% ALCOHOL, AND BD CHLORAPREP ON DRESSING CHANGE DAYS. THE INTERVENTION OR TREATMENT REQUIRED WAS TO BE ADMITTED TO THE HOSPITAL FOR FURTHER ASSESSMENT OR A NEW LINE. THE REPORTED PRODUCT WAS REPLACED WITH A DIFFERENT MANUFACTURER. THE TREATMENT WAS ABLE TO BE COMPLETED AFTER RESOLVING THE ISSUE, BUT THE FUNCTION LINE OF THE OTHER PRODUCT WAS POOR, SO IT WAS REPLACED AFTER 21 DAYS ON (B)(6) 2024. THERE WAS NO SECURITY WING ISSUE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS A BLOOD LOSS OF 400 ML, AND A BLOOD TRANSFUSION WAS NOT REQUIRED. IT WAS STATED ON THE REPORT THAT THE PATIENT HAD CURRENT AND PRE-EXISTING CONDITIONS THAT MAY BE RELATED TO EVENTS SUCH AS TYPE 1 DIABETES, OBESITY, OVERNIGHT NIV DUE TO OBESITY HYPOVENTILATION SYNDROME, END-STAGE RENAL FAILURE PROBABLY DUE TO DIABETIC NEPHROPATHY, A RECENT START ON HEMOLYSIS IN (B)(6) 2023, AN ATTEMPT TO START DIALYSIS VIA AVF BUT SUFFERED FREQUENT BLOWS WHEN NEEDLING AND VERY POOR FLOWS EVEN IF CANNULATION WAS SUCCESSFUL, AND A AND A FISTULA CLOTTED OFF AT THE START OF (B)(6) 2024. PATIENT HAD DISLODGEMENT OF PREVIOUS LINE CUFF (B)(6) 2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350600 | PALINDROME | CATHETER, HEMODIALYSIS, IMPLANTED | MSD | COVIDIEN LLC | 8888145015 | 2335200376 | 20884521013169 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | Hospitalization| R| O |