BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPS 550

    MDR report key: 172962 · Received June 16, 1998

    Report

    Report Number
    1423500-1998-01426
    Event Type
    Death
    Date Received
    June 16, 1998
    Date of Event
    May 18, 1998
    Report Date
    May 21, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL REQUESTED EVALUATION AFTER 2 PT'S REPORTEDLY EXPIRED WITHIN ONE MONTH OF EACH OTHER DURING HEMODIALYSIS TREATMENT ON DEVICE. INCIDENT: PT TOLERATED TREATMENT WITHOUT INCIDENT OR COMPLAINTS UNTIL 1/2 HOUR INTO TREATMENT. PT FELL ASLEEP AND WHEN HEALTH CARE PROFESSIONAL CHECKED PT SHE WAS FOUND UNRESPONSIVE. PT CODE WAS INITIATED. PT WAS TRANSPORTED TO AN EMERGENCY ROOM VIA AMBULANCE AND PRONOUNCED DEAD IN THE EMERGENCY ROOM. CAUSE OF DEATH: MYOCARDIAL INFARCTION. PT DID NOT TAKE CARDIAC MEDICATIONS. NO DEVICE MALFUNCTION WAS INDICATED AND HEALTH CARE PROFESSIONAL DOES NOT CONTRIBUTE THIS EVENT TO THE BAXTER 550 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPS 550 SPS 550 FKP BAXTER HEALTHCARE CORP. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death