GRANUFLO
Report
- Report Number
- 1225714-2015-08023
- 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
- K03K0497
- 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 GRANUFLO DRY ACID CONCENTRATE PRODUCT USED 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 GRANUFLO DRY ACID CONCENTRATE 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.
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) 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, 1225714-2015-07471. EVENT 2 ((B)(6) 2014)MFG NO.: 1713747-2015-999398, 1713747-2015-00490, 8030665-2015-0050, 2937457-2015-01564, 1225714-2015-08023, 1225714-2015-08024.
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY. NOTE: 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.
THIS IS ONE Of TWO EVENTS 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, 1225714-2015-0756T, 1225714-2015-07472, 8030665-2015-00501, 1225714-2015-07470 AND 1225714-2015-07471. 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.
ADDITIONAL INFO FROM THE CLINICAL INVESTIGATION WAS RECEIVED AND IS BEING REPORTED ACCORDINGLY. FOLLOW-UP REPORTS WILL BE SENT CONSECUTIVELY DAILY TO PROVIDE ALL INFO. THEREFORE, THIS IS ONE OF MULTIPLE FOLLOW-UP REPORTS BEING SUBMITTED TO PROVIDE THE CLINICAL INVESTIGATION INFO. AT THE TIME OF THE LAST FOLLOW-UP REPORT FOR THE CLINICAL INVESTIGATION, A NOTE WILL BE PROVIDED INDICATING SUCH. THIS IS ONE OF TWO EVENTS 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 1225714-2015-07471. EVENT 2 (DATE: (B)(6) 2014) MFG. REPORT NUMBERS: 1713747-2015-999398, 713747-2015-00490, 8030665-2015-00500, 2937457-2015-01564, 1225714-2015-08023, AND 1225714-2015-08024.
ADDITIONAL INFO FROM THE CLINICAL INVESTIGATION WAS RECEIVED AND IS BEING REPORTED ACCORDINGLY. FOLLOW-UP REPORTS WILL BE SENT DAILY TO PROVIDE ALL INFO. THIS IS THE SECOND OF MULTIPLE FOLLOW-UP REPORTS BEING SUBMITTED TO PROVIDE CLINICAL INVESTIGATION INFO. AT THE TIME OF THE LAST FOLLOW-UP REPORT FOR THE CLINICAL INVESTIGATION, A NOTE WILL BE PROVIDED. THIS IS ONE OF TWO EVENTS 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 1225714-2015-07471. EVENT 2 (DATE: (B)(6) 2014) MFG. REPORT NUMBERS: 1713747-2015-999398, 713747-2015-00490, 8030665-2015-00500, 2937457-2015-01564, 1225714-2015-08023, AND 1225714-2015-08024.
ADDITIONAL INFORMATION FROM THE CLINICAL INVESTIGATION (CI) IS BEING REPORTED. FOLLOW-UP REPORTS WILL BE SENT DAILY TO PROVIDE ALL INFO. A NOTE WILL BE PROVIDED AT THE TIME OF THE LAST CI FOLLOW-UP REPORT. THIS IS ONE OF TWO PT EVENTS CAPTURED AS TWO SYSTEM LEVEL COMPLAINT SETS UNDER THE FOLLOWING: 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 1225714-2015-07471. EVENT 2 (DATE: (B)(6) 2014) MFG. REPORT NUMBERS: 1713747-2015-999398, 713747-2015-00490, 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.
MEDICAL RECORDS PROVIDED BY THE PLAINTIFF'S ATTORNEY NOTED THE PATIENT EXPERIENCED EPISODES OF 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 FOR TACHYCARDIA AND HYPERKALEMIA. NEXT DAY, THE PATIENT WAS TRANSFERRED TO THE TRANSPLANT HOSPITAL FOR SPECIALIZED CARE WHERE DIAGNOSES OF ACUTE CHOLECYSTITIS, PANCREATITIS AND HYPERKALEMIA WERE MADE. THE PATIENT WAS ADMINISTERED INTRAVENOUS ANTIBIOTICS AND CALCIUM GLUCONATE, AND A CHOLECYSTECTOMY WAS COMPLETED. PANCREATITIS WAS SLOW TO IMPROVE. THE PATIENT WAS DISCHARGED TO HOME 12 DAYS POST HOSPITAL ADMISSION WITH PANCREATIS AND ON ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 727190 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Hospitalization| L| R |