BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS 2008 WITH TWISTER REVERSE FLOW DEVICE

    MDR report key: 3692368 · Received March 11, 2014

    Report

    Report Number
    8030665-2014-00216
    Event Type
    Death
    Date Received
    March 11, 2014
    Date of Event
    May 11, 2012
    Report Date
    February 24, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KOC
    PMA / PMN Number
    K022536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 EVAL A HISTORICAL RECORD REVIEW OF THE PRODUCTION LOTS IDENTIFIED THOUGH THE TREATMENT RECORD REVIEW HAS BEEN REQUESTED HOWEVER, HAS NOT BEEN COMPLETED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. RELATED MDRS: 1225714-2013-01236, 01237, 2937457-2014-00363, AND 1713747-2014-00116.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED ON OR ABOUT (B)(6) 2012 AFTER THE USE OF THE PRODUCT. MEDICAL RECORDS REVIEWED: ON (B)(6) 2012 THE PT WAS IN CLINIC FOR HEMODIALYSIS. AFTER ABOUT 3 HRS OF TREATMENT, THE PT REPORTED RIGHT LEG CRAMPS, A BOLUS OF NORMAL SALINE SOLUTION WAS GIVEN, THE PT BECAME UNRESPONSIVE, NO PULSE OR RESPIRATIONS WERE OBSERVED, CPR WAS INITIATED, AN ELECTRONIC CARDIAC DEFIBRILLATOR WAS APPLIED TO THE PT AND NO SHOCK WAS INDICATED. THE EMERGENCY RESPONSE TEAM WAS CALLED, UPON ARRIVAL THE PT WAS INTUBATED AND TRANSPORTED TO THE HOSPITAL, WHERE THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146319 FRESENIUS 2008 WITH TWISTER REVERSE FLOW DEVICE KOC FRESENIUS MEDICAL CARE NORTH AMERICA COMBISET ACCESS FLO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death 0.9% NS FMC 1000 ML| 2008 SERIES HEMODIALYSIS MACHINE| OPTIFLUX 180NRE DIALYZER FINISHED ASSY