BEUDAMED
    FDA Adverse Event Death Summary report: N

    2008K2 HEMODIALYSIS MACHINE

    MDR report key: 3932825 · Received March 11, 2014

    Report

    Report Number
    2937457-2014-00363
    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
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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. RELATED MDRS: 1225714-2013-01236, 1225714-2013-01237, 2937457-2014-00363, 8030665-2014-00216 AND 1713747-2014-00116.

    Description of Event or Problem · 1

    SYSTEM LEVEL K2. 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 PATIENT WAS IN CLINIC FOR HEMODIALYSIS. AFTER ABOUT 3 HOURS OF TREATMENT THE PATIENT REPORTED RIGHT LEG CRAMPS, A BOLUS OF NORMAL SALINE SOLUTION WAS GIVEN, THE PATIENT BECAME UNRESPONSIVE, NO PULSE OR RESPIRATIONS WERE OBSERVED, CPR WAS INITIATED, AN ELECTRONIC CARDIAC DEFIBRILLATOR WAS APPLIED TO THE PATIENT AND NO SHOCK WAS INDICATED. THE EMERGENCY RESPONSE TEAM WAS CALLED, UPON ARRIVAL THE PATIENT WAS INTUBATED AND TRANSPORTED TO THE HOSPITAL, WHERE THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146257 2008K2 HEMODIALYSIS MACHINE KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008K2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death 0.9% NS FMC 1000 ML| FRESENIUS 2008 TWISTER REVERSE FLOW DEVICE| OPTIFLUX 180NRE DIALYZER