BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DACII AUTOMATIC CENTRIFUGE

    MDR report key: 20176 · Received March 8, 1995

    Report

    Report Number
    MW1005365
    Event Type
    Malfunction
    Date Received
    March 8, 1995
    Date of Event
    February 22, 1995
    Report Date
    March 2, 1995
    Manufacturer
    BAXTER DIAGNOSTICS, INC.
    Product Code
    JQC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CELL WASHER REPEATEDLY BLEW MAIN FUSE ON BACK OF UNIT. THIS WAS DUE TO AN IMPERFECTION IN THE DESIGN OF THE WASHER. THE SPLASHGUARD SETS TOO HIGH ABOVE THE LIP OF THE LINER, WHICH ALLOWS THE CONDUCTIVE SALINE SOLUTION TO SEEP UNDERNEATH THE MAGNET. THIS LEAVES A HIGH RISK OF SALINE CROSSING THE CONTACTS, THUS LEAVING THE UNIT SUSCEPTIBLE TO A SHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DACII AUTOMATIC CENTRIFUGE DACII AUTOMATIC CENTRIFUGE JQC BAXTER DIAGNOSTICS, INC. B5054-2

    Patients

    Seq Age Sex Outcome Treatment
    1 *