GRANUFLO
Report
- Report Number
- 1225714-2013-00659
- Event Type
- Death
- Date Received
- April 24, 2013
- Date of Event
- June 7, 2012
- Report Date
- March 27, 2013
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K030497
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- ATTORNEY
Narratives
THIS REPORTED EVENT IS ON THE SAME PT INVOLVING TWO SEPARATE PRODUCTS AND ASSOCIATED WITH MDR # 1225714-2013-00660
NEW INFORMATION FROM THE PLAINTIFF'S ATTORNEY ALLEGES THE PATIENT EXPIRED APPROXIMATELY 14 MONTHS AFTER THE REPORTED EVENT. MEDICAL RECORDS DO NOT CONTAIN HOSPITAL RECORDS, DIAGNOSES, TREATMENT SHEETS, PROGRESS NOTES, LAB/DIAGNOSTIC RESULTS OR CAUSE OF ALLEGED DEATH FROM THIS DATE OR TIME PERIOD FOR REVIEW. MEDICAL RECORDS DO NOT CONTAIN A DEATH CERTIFICATE OR AUTOPSY REPORT FOR THIS ALLEGED DEATH. THERE IS NO DOCUMENTATION IN THE MEDICAL RECORD THAT SHOWS THAT THIS PATIENT EXPIRED. UPON RECEIPT, NEW ADDITIONAL INFORMATION WILL BE PROCESSED AND SUBMITTED ACCORDINGLY.
THE SYSTEM LEVEL REVIEW OF THE 2008K DEVICE AND CONCOMITANT PRODUCTS FOUND NO INDICATION THAT THE PRODUCTS CAUSED OR CONTRIBUTED IN ANY WAY TO THE CLINICAL EVENT. UPON RECEIPT OF ADDITIONAL INFORMATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS ONE OF SIX DEVICE REPORTS ASSOCIATED WITH THIS EVENT: 2937457-2013-00259, 8030665-2013-00649, 1713747-2013-00489, 1713747-2013-99957, 1225714-2013-00659, 1225714-2013-00660.
MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY THE POST MARKET CLINICAL STAFF. THE MEDICAL RECORD INDICATED THE PATIENT CODED DURING HEMODIALYSIS TREATMENT WHILE USING MULTIPLE FMCNA PRODUCTS. IN ADDITION, THE PLAINTIFFS ATTORNEY ALLEGED THAT THE USE OF BOTH GRANUFLO AND NATURALYTE PRODUCTS CAN RESULT IN HIGH BICARBONATE LEVELS. FURTHERMORE, IT WAS ALLEGED THAT THE PATIENT WAS HOSPITALIZED AND UNDERWENT OPEN HEART SURGERY A WEEK LATER INCLUDING THE IMPLANTATION OF A PACEMAKER MOST RECENT BICARBONATE RESULT RECEIVED TAKEN ON (B)(6) 2012 WAS WITHIN NORMAL LEVELS OF 23. THIS EVENT IS REGARDING A YOUNG ESRD (END-STAGE RENAL DISEASE) PATIENT WITH CONGESTIVE HEART FAILURE WHO REPORTEDLY CODED APPROXIMATELY ONE HOUR AFTER INITIATION OF HEMODIALYSIS, EMERGENCY MEDICAL SERVICES LOG AND HOSPITALIZATION RECORDS HAVE NOT BEEN MADE AVAILABLE TO FOR REVIEW. THERE WAS NO PRODUCT MALFUNCTION DURING HEMODIALYSIS AND PATIENT HAS RETURNED TO HER USUAL DIALYSIS TREATMENTS. THE ACTUAL FMCNA PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION AND NO PRODUCT IDENTIFIERS WERE PROVIDED. A MANUFACTURING REVIEW WAS PERFORMED OF THE PRODUCTS SHIPPED TO THE DIALYSIS CENTER DURING A THREE (3) MONTH TIME FRAME ((B)(6) 2012) FOR POTENTIAL FORMULAS AND LOT NUMBERS RECEIVED. A RECORD REVIEW WAS PERFORMED ON ALL IDENTIFIED LOTS SINCE THERE WAS NO CLEAR INDICATION AS TO WHAT LOTS COULD HAVE BEEN POTENTIALLY USED DURING TREATMENT. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. BASED ON THE CURRENT INFORMATION THE CAUSALITY BETWEEN FRESENIUS PRODUCT TO THE PATIENT'S EVENT (CODING) CANNOT BE CONFIRMED. THIS IS ONE EVENT REPORTED FOR THE SAME PATIENT INVOLVING SIX SEPARATE PRODUCTS, ASSOCIATED MDRS # 1713747-2013-00489, 1713747-2013-99957, 2937457-2013-00259, 1225714-2013-00659, 8030665-2013-00649.
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PLAINTIFF EXPERIENCED A CARDIOVASCULAR EVENT ON (B)(6) 2012, AFTER USE OF THE PRODUCT.
ADDITIONAL INFORMATION FROM PLAINTIFFS ATTORNEY INDICATED THE PATIENT EXPERIENCED A SUDDEN CARDIAC EVENT AND SUBSEQUENTLY EXPIRED APPROXIMATELY 14 MONTHS LATER.
THE FOLLOWING IS BASED ON THE MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY. ON (B)(6) 2012, PATIENT CODED DURING DIALYSIS TREATMENT ROUTINE DIALYSIS TREATMENT STARTED AT 13 32. THE PATIENT WAS ALERT, RESTING COMFORTABLY AND DENIED ANY COMPLAINTS. TREATMENT INITIATED WITHOUT PROBLEM AT 14-46 (APPROXIMATELY 1 HOUR AND 14 MINUTES) NURSE FOUND PATIENT CODING, BLUE IN COLOR AND UNRESPONSIVE WITHOUT PULSE. ONE (1) DEFIBRILLATION SHOCK WAS DELIVERED AND OXYGEN AT HIGH CONCENTRATION WAS PROVIDED PER AMBU BAG 911 WAS CALLED AND CPR (CARDIOPULMONARY RESUSCITATION) STARTED AFTER SHOCK WAS DELIVERED. PATIENT'S COLOR IMPROVED AND AGONAL BREATHS WERE TAKEN, CPR CONTINUED UNTIL EMS (EMERGENCY MEDICAL SERVICES) ARRIVED AND TRANSFERRED PATIENT TO A STRETCHER FOR TRANSPORT TO HOSPITAL. SINCE THIS EVENT THE PATIENT HAS RETURNED TO HER ROUTINE DIALYSIS TREATMENTS (B)(6) 2012 VITAL SIGNS SIT BP PRE 140/98,POST 40/PALP,TEMP PRE 95 3, POST 98 6 PULSE PRE 102R, POST 0R, RESPS PRE 18, POST 0 DIALYSIS STANDING ORDERS ADMIT PATIENT TO FMC-OWOSSO UNIT ON (B)(6) 2012, TREATMENTS PER WEEK (3), LENGTH OF TREATMENT 3 0-3 5 HRS, DIALYZER F 180, DIALYSATE 2K 2.0CA BICARB 33, ACCESS GRAFT LEFT UPPER ARM, BLOOD FLOW RATE 250 BFR, DIALYSATE FLOW RATE 500 DFR. MEDS ENGENX B VL 40 00 IM,VENOFER 100 MG 100 00 IVP 3XWK, ZEMPLAR MULTIDOSE VL 6 00 IVP 3XWK, EPOGEN 24000.00 IVP 3XWK ZONE PERFECT PROTEIN BAR (PO) HEPARIN-PORK 1000 UNITS/ML 1 00 IVP 3XWK. HEPARIN-PORK 1000 UNITS/ML 2 00 IVP 3XWK, CALCITRIOL 25 MCG 1XDAY, RENAGEL/8OC MG 3XDAY, SENSIPAR/60 MG 1 XDAITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176295 | GRANUFLO | DRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Hospitalization| L| O| R| S |