BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD

    MDR report key: 493762 · Received October 29, 2003

    Report

    Report Number
    MW1029998
    Event Type
    Malfunction
    Date Received
    October 29, 2003
    Date of Event
    October 9, 2003
    Report Date
    October 29, 2003
    Manufacturer
    BARD VASCULAR SYSTEMS DIVISION
    Product Code
    KRI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PERFUSIONIST ASSEMBLED BYPASS MACHINE AND DISCOVERED HEMOCONCENTRATOR WAS DEFECTIVE AND LEAKING FLUID AT END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD HEMOCONCENTRATOR KRI BARD VASCULAR SYSTEMS DIVISION HC70TS 110984A

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other