BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIFLUX 160NRE

    MDR report key: 4008130 · Received March 11, 2014

    Report

    Report Number
    1713747-2014-00115
    Event Type
    Death
    Date Received
    March 11, 2014
    Date of Event
    June 10, 2011
    Report Date
    February 24, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS ASSOCIATED WITH MDRS #1225714-2013-01235, 2937457-2013-00091, 1713747-2014-00115, 99915, 8030665-2014-00215.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A SAMPLE WAS NOT PROVIDED FOR EVAL. A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT SAMPLE. AS NO LOT NUMBER WAS PROVIDED BY THE COMPLAINANT, A RECORD REVIEW WAS PERFORMED ON EACH LOT NUMBER SHIPPED TO THE CLINIC IN THE THREE MONTHS LEADING UP TO THE REPORTED EVENT. THE RECORD REVIEW FOUND (B)(4) LOT NUMBERS SHIPPED TO THE USER FACILITY DURING THAT TIME PERIOD. THE CAPA TRIGGER LIMIT FOR THE REPORTED SYMPTOM CODES WAS NOT EXCEEDED BY ANY OF THE AFOREMENTIONED LOT NUMBERS. THE BATCH PRODUCTION RECORDS FOR EACH LOT WERE REVIEWED AND NO NON-CONFORMANCES WERE NOTED DURING THE MFG PROCESS OF ANY OF THE LOTS. ALL PROCESSES MET REQUIREMENTS AND ALL LOT RELEASE CRITERION WERE MET. MEDICAL RECORDS REVIEW: THIS EVENT HAS BEEN REPORTED AS A SERIOUS INJURY, ALTHOUGH IT IS UNDETERMINED IF THERE IS A REASONABLE SUSPECTED CAUSAL RELATIONSHIP BETWEEN THE PRODUCTS AND THE EVENT IN THIS PT WITH MULTIPLE CO MORBIDITIES ASSOCIATE WITH A HIGH MORTALITY RATE. THERE IS NO HISTORY OF SPECIFIC MALFUNCTION OR PRODUCT BEING OUT OF SPECS AND THE MEDICAL RECORDS RECEIVED ARE INCOMPLETE, AND THE INFO REVIEWED IS CONTRADICTORY IN ITSELF. THE ALLEGATIONS OF SERIOUS INJURY REMAIN SPECULATIVE IN NATURE. THE SYSTEM LEVEL REVIEW OF THE CONCOMITANT PRODUCTS FOUND NO INDICATION THAT THE PRODUCTS CAUSED OR CONTRIBUTED TO THE PT EVENT.

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY. THIS IS ONE EVENT FOR THE SAME PT INVOLVING FIVE SEPARATE PRODUCTS; ASSOCIATED MDR NUMBERS:1225714-2013-01235, 2937457-2013-00091, 8030665-2014-00215, 1713747-2014-00115, 99915.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW; WHICH WILL INCLUDE AN INVESTIGATION OF ALL POTENTIAL FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT. PRODUCT IDENTIFIERS WERE NOT PROVIDED FOR EVALUATION A HISTORICAL RECORD REVIEW OF THE PRODUCTION LOTS IDENTIFIED THROUGH THE TREATMENT RECORD REVIEW HAS BEEN REQUESTED HOWEVER, HAS NOT BEEN COMPLETED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS MEDWATCH REPORT IS ASSOCIATED WITH MDRS #1225714-2014-01235, 2937457-2013-00091, 1713747-2014-00115, 1713747-2014-99915, 8030665-2014-00215.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON MEDICAL RECORDS PROVIDED BY THE PLAINTIFF'S ATTORNEY. ON (B)(6) 2011 DURING THE PT'S DIALYSIS TREATMENT AT 4:45PM. PT WAS FOUND UNRESPONSIVE, CPR WAS INITIATED AND AN AUTO ELECTRONIC DEFIBRILLATOR WAS APPLIED TO THE PT, ONE SHOCK WAS DELIVERED. THE EMERGENCY MEDICAL SERVICE (EMS) TEAM WAS CALLED. CPR WAS CONTINUED UNTIL THE EMS TEAM ARRIVED. THE PT'S PULSE AND RESPIRATIONS WERE REGAINED PRIOR TO THE PT'S TRANSPORT TO THE HOSPITAL. NO FURTHER INFO WAS AVAILABLE IN THE MEDICAL RECORD AFTER TRANSPORT. THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED ON (B)(6) 2011 AFTER THE USE OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS ALLEGED BY THE ATTORNEY FOR THE PLAINTIFF THAT "AS A RESULT OF EXPOSURE TO GRANUFLO" THE PLAINTIFF "SUFFERED INJURIES AND DAMAGES, INCLUDING SEVERE AND PERMANENT BODILY INJURY, PAIN AND SUFFERING, MENTAL ANGUISH, AND LOSS OF CAPACITY FOR THE ENJOYMENT OF LIFE", INCURRED "THE EXPENSES OF MEDICAL AND NURSING CARE, AND ULTIMATELY DEATH". IT WAS ALSO ALLEGED THAT DECEDENT "EXPERIENCED SEVERE EMOTIONAL DISTRESS" AS A RESULT OF PRODUCT USE. MEDICAL RECORD REVIEW: (B)(6) 2011 DIALYSIS TREATMENT AT 1645 PATIENTS FOUND UNRESPONSIVE, CPR INITIATED AED APPLIED PT SHOCKED ONCE, THE EMERGENCY MEDICAL RESPONSE (EMR) TEAM WAS CALLED. CPR WAS CONTINUED UNTIL THE EMR TEAM ARRIVED. PULSE AND RESP WERE REGAINED PRIOR TO PATIENT TRANSPORT TO THE HOSPITAL. NO FURTHER INFORMATION WAS AVAILABLE IN THE MEDICAL RECORDS AFTER TRANSPORT. LEGAL FILE REPORTS THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND EXPIRED AT APPROXIMATELY 11:00PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146091 OPTIFLUX 160NRE FJI FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CUSTOM COMBI SET| OPTIFLUX 160NRE DIALYZER| GRANUFLO CONCENTRATE| DIALYSIS MACHINE 2008K| SALINE 0.9%