BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE CARTRIDGE

    MDR report key: 29620 · Received January 10, 1996

    Report

    Report Number
    29620
    Event Type
    Malfunction
    Date Received
    January 10, 1996
    Date of Event
    December 12, 1995
    Report Date
    December 15, 1995
    Manufacturer
    COBE RENAL CARE, INC.
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS ON MACHINE FOR TREATMENT APPROX 2 HRS. MACHINE STOPPED AFTER ALARMING "BLOOD PUMP IN WRONG POSITION." MACHINE WOULDN'T RESET. TECHNICIAN TRIED TO RETURN PT'S BLOOD BACK INTO PT. AFTER A COUPLE OF ATTEMPTS, CARTRIDGE BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE CARTRIDGE DIALYZER FJI COBE RENAL CARE, INC. 11A15385

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other