BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLUX H CAPILLARY DIALYZER

    MDR report key: 1051638 · Received May 23, 2008

    Report

    Report Number
    9611369-2008-00348
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 25, 2008
    Manufacturer
    GAMBRO DIAYLZATOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    K030592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME BEING THERE IS NO INFO THAT REASONABLY INDICATES THAT OUR PROD CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    SHORTLY AFTER A PT COMMENCED HIS DIALYSIS TREATMENT, THE PT EXPERIENCED NAUSEA WITH VOMITING, STOMACH PAIN AND HYPOTENSION. THE PT THEN BECAME UNRESPONSIVE. THE PT RESPONDED TO A FLUID BOLUS. AN ECHOCARDIOGRAM WAS DONE AND ACCORDING TO THE PHYSICIAN THE PT REC'D INTRAVENOUS (IV) STEROIDS, BENADRYL AND XANAX. THE PT'S BLOOD LOSS WAS AROUND 196 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLUX H CAPILLARY DIALYZER KDI GAMBRO DIAYLZATOREN GMBH POLYFLUX 170 H UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention