NATURALYTE
Report
- Report Number
- 1225714-2015-08024
- Event Type
- Injury
- Date Received
- November 2, 2015
- Date of Event
- January 20, 2014
- Report Date
- October 6, 2015
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K981043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVALUATION AND PRODUCT IDENTIFIERS WERE NOT PROVIDED. THE SPECIFIC PRODUCTION LOT NUMBER AND CATALOG NUMBER OF NATURALYTE DRY BICARBONATE PRODUCT USING DURING PT TREATMENT COULD NOT BE IDENTIFIED. TO COMPLETE THE INVESTIGATION, A SALES SEARCH WAS CONDUCTED TO IDENTIFY PRODUCTION LOTS SOLD TO THE CUSTOMER THREE MONTHS (10/21/2013 - 01/20/2014) PRIOR TO THE ALLEGED COMPLAINT EVENT. NO NATURALYTE DRY BICARDONATE WAS IDENTIFIED DURING THIS SALES SEARCH. A RETROSPECTIVE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCE REPORTS AND/OR ABNORMALITIES. A DEFINITIVE CONCLUSION REGARDING THE INVOLVEMENT OF THE PRODUCT COULD NOT BE DETERMINED WITHOUT A PHYSICAL EXAMINATION OF A COMPLAINT SAMPLE AND THE ALLEGED COMPLAINT EVENT COULD NOT BE CONFIRMED. THIS IS ONE OF TWO EVENTS ASSOCIATED WITH ONE PT CAPTURED AS TWO SYSTEM LEVEL COMPLAINT SETS: EVENT ((B)(6) 3013) MFG NO.: 1713747-2015-999398, 1713747-2015-00491, 1225714-2015-07561, 1225714-2015-07472, 8030665-2015-00501, 1225714-2015-07470, 1225714-2015-07471. EVENT 2 ((B)(6) 2014)MFG NO.: 1713747-2015-999398, 1713747-2015-00490, 8030665-2015-00500, 2937457-2015-01564, 1225714-2015-08023, 1225714-2015-08024. UPON RECEIPT OF ADD'L NFO, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY. MEDICAL RECORDS RECEIVED FROM THE PLAINTIFF'S ATTORNEY FOR THE INITIALLY REPORTED EVENT (SEPSIS WITH DEATH OUTCOME) WERE REVIEWED AND REVEALED THE COMPLAINT AS A SYSTEM-LEVEL WITH ON-SET OF THE EVENT OCCURRING LATE FALL ((B)(6) 2013) WITH SEQUELA THROUGH THE PATIENT'S DEMISE ON (B)(6) 2014. HOWEVER IN SPITE OF THIS, THE EVENT OCCURRING ON (B)(6) 2014., (TACHYCARDIA DURING DIALYSIS TREATMENT IN CLINIC ON A DIFFERENT MACHIN) WAS CAPTURED AS A SECOND SYSTEM-LEVEL COMPLAINT SET (ALTHOUGH IT APPEARS THIS IS A MORBID CONDITION FOLLOWING/OCCURRING AS A CONSEQUENCE OF THE INITIAL EVENT.) BOTH SYSTEM-LEVEL COMPLAINT SETS ARE BEING REFERRED TO ONE ANOTHER WITHIN THESE REGULATORY REPORTS. THIS IS ONE OF TWO EVENT ASSOCIATED WITH ONE PATIENT CAPTURED AS TWO SYSTEM LEVEL COMPLAINT SETS UNDER THE FOLLOWING MFG. REPORT NUMBERS: EVENT ONE (EVENT DATE: (B)(6) 2013) MFG. REPORT NUMBERS: 1713747-2015-999398, 1713747-2015-00490, 1225714-2015-07561, 1225714-2015-07472, 8030665-2015-00500, 1225714-2015-07470 AND 1228714-2015-07471. EVENT TWO (EVENT DATE: (B)(6) 2014) MFG. REPORT NUMBERS: 1713747-2015-999398, 713747-2015-00491, 8030665-2015-00501, 2937457-2015-01564, 1225714-2015-08023, AND 1225714-2015-08024.
NI.
ADD'L INFO FROM THE CLINICAL INVESTIGATION WAS RECEIVED AND IS BEING REPORTED ACCORDINGLY. F/U REPORTS WILL BE SENT CONSECUTIVELY DAILY TO PROVIDE ALL INFO. THEREFORE, THIS IS ONE OF MULTIPLE F/U REPORTS BEING SUBMITTED TO PROVIDE THE CLINICAL INVESTIGATION INFO. AT THE TIME OF THE LAST F/U REPORT FOR THE CLINICAL INVESTIGATION, A NOTE WILL BE PROVIDED INDICATING SUCH. THIS IS ONE OF TWO EVENTS ASSOCIATED WITH ONE PT CAPTURED AS TWO SYSTEM LEVEL COMPLAINT SETS UNDER THE FOLLOWING MFG REPORT NUMBERS: EVENT 1 (DATE: (B)(6) 2013) MFG REPORT NUMBERS: 1713747-2015-999398, 00491, 1225714-2015-07561, 07472, 07470, 07471, AND 8030665-2015-00501. EVENT 2: (DATE: (B)(6) 2014) MFG REPORT NUMBERS: 1713747-2015-999398, 00490, 2937457-2015-01564, 1225714-2015-08023, 008024, AND 8030665-2015-00500.
ADDITIONAL INFORMATION FROM THE CLINICAL INVESTIGATION (CI) IS BEING REPORTED. FOLLOW-UP REPORTS WILL BE SENT DAILY TO PROVIDE ALL INFORMATION. A NOTE WILL BE PROVIDED AT THE TIME OF THE LAST CL FOLLOW-UP REPORT. THIS IS ONE OF TWO PATIENT EVENTS CAPTURED AS TWO SYSTEM LEVEL COMPLAINT SETS UNDER THE FOLLOWING: EVENT 1 (DATE: (B)(6) 2013) MFG NO: 1713747-2015-999398, 1713747-2015-00491, 1225714-2015-07561, 1225714-2015-07472, 8030665-2015-00501, 1225714-2015-07470 AND 1225714-2015-07471. EVENT 2 (DATE: (B)(6) 2014) MFG NO: 1713747-2015-999398,1713747-2015-00490, 8030665-2015-00500, 2937457-2015-01564, 1225714-2015-08023, AND 1225714-2015-08024.
ADDITIONAL INFORMATION FROM THE CLINICAL INVESTIGATION WAS RECEIVED AND IS BEING REPORTED ACCORDINGLY. FOLLOW-UP REPORTS WILL BE SENT DAILY TO PROVIDE ALL INFORMATION. THIS IS THE SECOND OF MULTIPLE FOLLOW-UP REPORTS BEING SUBMITTED TO PROVIDE CLINICAL INVESTIGATION INFORMATION. AT THE TIME OF THE LAST FOLLOW-UP REPORT FOR THE CLINICAL INVESTIGATION, A NOTE WILL BE PROVIDED. THIS IS ONE OF TWO EVENT ASSOCIATED WITH ONE PATIENT CAPTURED AS TWO SYSTEM LEVEL COMPLAINT SETS UNDER THE FOLLOWING MFG. REPORT NUMBERS: EVENT 1 (DATE: (B)(6), 2013) MFG. REPORT NUMBERS: 1713747-2015-999398, 1713747-2015-00491, 1225714-2015-07561, 1225714-2015-07472, 8030665-2015-00501, 1225714-2015-07470 AND 1225714-2015-17471. EVENT 2 (DATE: (B)(6) 2014) MFG. REPORT NUMBERS: 1713747-2015-999398, 1713747-2015-00490, 8030665-2015-00500, 2937457-2015-01564, 1225714-2015-08023 AND 1225714-2015-08024.
THE SYSTEM LEVEL REVIEW OF THE 2008T MACHINE AND CONCOMITANT PRODUCTS FOUND THAT THE SERIAL NUMBER OF THE DURABLE EQUIPMENT AND LOT NUMBERS OF THE CONCOMITANT PRODUCTS USED DURING THE EVENT TO BE UNKNOWN AND UNAVAILABLE FOR EVALUATION. AS EVALUATION OF COMPLAINT, RETAIN, OR COMPANION SAMPLES COULD NO BE PERFORMED, THERE IS NO INFO AVAILABLE TO CONCLUDE THAT THE PRODUCTS CAUSED OR CONTRIBUTED TO THE EVENT. THIS IS ONE OF TWO EVENTS ASSOCIATED WITH ONE PT CAPTURED AS TWO SYSTEM LEVEL COMPLAINT SETS UNDER THE FOLLOWING MFG REPORT NUMBERS: EVENT ((B)(6) 3013) MFG NO.:1713747-2015-999398, 1713747-2015-00491, 1225714-2015-07561, 1225714-2015-07472, 8030665-2015-00501, 1225714-2015-07470, 1225714-2015-07471, EVENT 2 ((B)(6) 2014) MFG NO.: 1713747-2015-999398, 1713747-2015-00490, 8030665-2015-00500, 2937457-2015-01564, 1225714-2015-08023, 1225714-2015-08024. UPON RECEIPT OF ADD'L INFO, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
ADD'L INFO WAS REQUESTED REGARDING THE TIME FRAME FOR EXPOSURE TO THE ALLEGED CONTAMINATED LOT NUMBER. MEDICAL RECORDS DON'T REVEAL IF THE PT WAS EXPOSED TO RECALLED PRODUCT, THE LOT NUMBER OR NAME OF THE CONCENTRATE USED DURING DIALYSIS. MEDICAL RECORDS DO NOT ALLEGE A RECALLED OR CONTAMINATED PRODUCT RESULTED IN SEPSIS. BEFORE (B)(6) 2013 THE PT WAS RECEIVING HOME HEMODIALYSIS ON THE 2008K MACHINE. FOLLOWING DISCHARGE FROM THE HOSPITAL (B)(6) 2015, THE PT BEGAN CLINIC HEMODIALYSIS ON THE 2008T MACHINE. A 160NRE DIALYZER WAS USED FOR HOME AND CLINIC THERAPY. MEDICAL RECORDS DO NOT INDICATE SPECIFIC CONCENTRATES USED FOR HOME OR CLINIC DIALYSIS. MEDICAL RECORDS REVEAL THE CAUSE OF SEPSIS WAS NOT DETERMINED. THERE WERE TOW HOSPITALIZATIONS FOR SEPSIS ((B)(6) 2013 AND (B)(6) 201) WITHOUT RESOLUTION AND NO ETIOLOGY. THE PT WAS DIAGNOSED WITH CHOLECYSTITIS (B)(6) 2014 WITH A CHOLECYSTECTOMY (B)(6) 2014. PT ALSO HAD NON-GALLBLADDER RELATED SEPSIS ON (B)(6) 2014 WITH NO ETIOLOGY. MEDICAL RECORDS DON'T INDICATE CAUSAL RELATIONSHIP BETWEEN THE FRESENIUS PRODUCTS AND SEPSIS. MEDICAL RECORDS REPORT THE PT DEVELOPED SEPSIS AFTER STARTING HEMODIALYSIS IN (B)(6) 2013. MEDICAL RECORDS REPORT A PAST MEDICAL HISTORY OF REJECTING THE KIDNEY CAUSING THE USE OF CORTICOSTEROIDS, CELLCEPT DECREASE IMMUNITY AND MASK INFLAMMATORY SYMPTOMS AND INTRODUCTION OF DIALYSIS INTO A COMPROMISED PHYSIOLOGICAL STATE WHERE HUMAN ELEMENT EXISTS COULD REASONABLY CONTRIBUTE TO SEPSIS. NO CAUSE FOR INFECTIOUS PROCESS WAS DETERMINED (EXCEPT (B)(6) 2014). THERE'S NO DOCUMENTATION THE SEPSIS OF (B)(6) 2013 RESOLVED EVIDENCED BY FREQUENT HOSPITALIZATIONS IN A SHORT TIME. PULSELESS ELECTRICAL ACTIVITY OCCURRED AFTER RECEIVING LOPRESSOR AND THE COMPROMISED CARDIAC STATUS WOULD CONTRIBUTE TO PT'S EVENTUAL PEA AND DEATH. ADD'L INFO FROM THE CLINICAL INVESTIGATION (CI) HAS BEEN REPORTED. THIS "IS THE" LAST F/U REPORT TO PROVIDE THE CI. THIS IS ONE OF TWO EVENTS ASSOCIATED WITH ONE PT CAPTURED AS TWO SYSTEM LEVEL COMPLAINT SETS: EVENT ((B)(6) 3013) MFG NO.: 1713747-2015-999398, 1713747-2015-00491, 1225714-2015-07561, 1225714-2015-07472, 8030665-2015-00501, 1225714-2015-07470, 1225714-2015-07471EVENT 2 ((B)(6) 2014)MFG NO.: 1713747-2015-999398, 1713747-2015-00490, 8030665-2015-0050, 2937457-2015-01564, 1225714-2015-08023,1225714-2015-08024.
MEDICAL RECORDS PROVIDED BY THE PLAINTIFFS ATTORNEY NOTED THE PATIENT EXPERIENCED EPISODES FO TACHYCARDIA AND ELEVATED POTASSIUM LEVEL AT 7.5 DURING OUTPATIENT HEMODIALYSIS TREATMENT. CONSEQUENTLY, THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT WHERE THE TACHYCARDIA WAS CONFIRMED. THE PATIENT WAS TREATED FRO TACHYCARDIA AND HYPERKALEMIA. NEXT DAY, THE PATIENT WAS TRANSFERRED TO THE TRANSPLANT HOSPITAL FOR SPECIALIZED CARE WHERE DIAGNOSES FO ACUTE CHOLECYSTITIS, PANCREATITIS AND HYPERKALEMIA WERE MADE. THE PATIENT WAS ADMINISTERED INTRAVENOUS ANTIBIOTICS AND CALCIUM GLUCONATE, AND CHOLECYSTECTOMY WAS COMPLETED. PANCREATITIS WAS SLOW TO IMPROVE. THE PATIENT WAS DISCHARGED TO HOME 12 DAYS POST HOSPITAL ADMISSION WITH PANCREATITIS AND ON ANTIBIOTICS.
ADD'L INFO NOTED: POST FAILED KIDNEY TRANSPLANT, THE PT WAS ON HOME HEMODIALYSIS (HD) STARTING IN EARLY FALL. THE PT WENT TO THE ER WITH INTERMITTENT FEVER OF UP TO 105F. PT ALSO HAD BODY ACHES, WEAKNESS AND DECREASED APPETITE WITH NAUSEA/VOMITING. THE PT WAS DIAGNOSED WITH UNSPECIFIED FEVER, TREATED WITH IV ROCEPHIN AND RELEASED WITH ANTIBIOTICS. APPROX 1 MONTH LATER, THE PT DISCONTINUED DIALYSIS TREATMENT 20 TO 28 MINUTES EARLY (AGAINST MEDICAL ADVICE) TO USE THE BATHROOM. THE PT HAD DIARRHEA AND WAS NOTED TO HAVE A LOW-GRADE FEVER FOR ABOUT THREE WEEKS. PT PRESENTED TO THE ER WITH FEVER, CHILLS, BODY ACHES AND PRODUCTIVE COUGH WITH YELLOW SPUTUM. PT WAS ADMITTED AND TREATED FOR ENTEROCOCCUS SEPSIS , BUT CONTINUED TO HAVE FEVER AND RESPIRATORY SYMPTOMS. THE PT'S DIALYSIS CATHETER WAS REPLACED. FOUR DAYS POST ADMISSION, PT WAS TRANSFERRED TO TRANSPLANT CTR. PT HAD AN IMMATURE AV FISTULA. WORK-UP FOR SOURCE OF FEVER WAS UNREVEALING; PT WAS DISCHARGED ABOUT 22 DAYS LATER, AFEBRILE AND STABLE. THE NEXT DAY, PT ARRIVED IN CLINIC FOR DIALYSIS BUT DID NOT RECEIVE DIALYSIS DUE TO TACHYCARDIA. PT WENT TO THE HOSP WITH TACHYCARDIA AND WAS DIAGNOSED WITH PANCREATITIS AND ACUTE CHOLECYSTITIS. NEXT DAY, PT WAS ADMITTED TO THE TRANSPLANT HOSP WHERE DIALYSIS AND IV ANTIBIOTICS WERE STARTED. SEPSIS SECONDARY TO PANCREATITIS AND A THICKENED GALLBLADDER WITH STONES WERE CONFIRMED. PT WAS DISCHARGED 5 DAYS LATER WITH ANTIBIOTICS. FIVE DAYS POST DISCHARGE, THE PT EXPERIENCED TACHYCARDIA DURING DIALYSIS TREATMENT; HEART RATE EXCEEDED 200 WITH A 7.5 POTASSIUM LEVEL. DIALYSIS WAS STOPPED AND PT WAS SENT TO THE ER. CHOLECYSTITIS AND PANCREATITIS WERE DIAGNOSED, IV ANTIBIOTICS AND CALCIUM GLUCONATE WERE ADMINISTERED. PT WAS TAKEN TO TRANSPLANT HOSP WHERE A CHOLECYSTECTOMY WAS DONE. PT WAS DISCHARGED 11 DAYS LATER WITH JACKSON PRATT DRAINS. IN CLINIC DIALYSIS TREATMENT CONTINUED, AND 37 DAYS POST LAST DISCHARGE, PT WAS SENT TO ER FROM THE PHYSICIAN'S OFFICE WITH LEFT FLANK PAIN. LAB WORK WAS DONE AND PT WAS ADMITTED WITH LACTIC ACID ELEVATION, FEVER AND LEUKOCYLOSIS. PT WAS TRANSFERRED TO THE TRANSPLANT HOSP FOR EVAL. UPON ARRIVAL, PT WAS CONFUSED, THE ADMITTING DIAGNOSIS WAS SEPSIS WITH SHOCK AND ALTERED MENTAL STATUS. PT WAS TREATED WITH ANTIBIOTICS AND ANTIFUNGALS AND FOUND TO HAVE DEVELOPED CARDIOMYOPATHY AND HYPOTENSION WITH DECREASE IN EJECTION FRACTION. EIGHTEEN DAYS LATER, PT WAS DISCHARGED TO LONG-TERM CARE CTR FOR REHAB AND CONTINUED TREATMENT FOR CARDIAC ISSUES. ELEVEN DAYS POST REHABILITATION CTR ADMISSION, PT WAS DISCHARGED WITH A LIFE VEST. THE PT AGAIN BEGAN CLINIC DIALYSIS. APPROX 1 MONTH LATER, THE PT PRESENTED TO THE CLINIC FOR DIALYSIS AND WAS SENT TO THE ER FOR ELEVATED HEART RATE. IV LOPRESSOR WAS ADMINISTERED, THIS DECOMPENSATED THE PT'S CONDITION, CAUSING THE PT TO GO INTO PULSELESS ELECTRICAL ACTIVITY (PEA). CPR WAS PERFORMED, A LOW BLOOD PRESSURE AND PULSE WERE OBTAINED. PT WAS KEPT ICU OVERNIGHT AND TRANSFERRED TO TRANSPLANT HOSP NEXT DAY. FOUR DAYS LATER, THE PT WENT INTO PEA, CODED AND EXPIRED. CAUSE OF DEATH ON DEATH CERTIFICATE NOTED: BIVENTRICULAR HEART FAILURE SECONDARY TO SEPSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 726133 | NATURALYTE | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Hospitalization| L| R |