BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOLIANCE

    MDR report key: 512776 · Received February 25, 2004

    Report

    Report Number
    512776
    Event Type
    Other
    Date Received
    February 25, 2004
    Date of Event
    December 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    DTR
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FACILITY HAS HAD PROBLEMS FOR ABOUT A YEAR WITH CONTROL VALUES FOR PROTIMES AND PTTS [PROTHROMBIN TIME] ON THE MLA 1400 [INSTRUMENT]. FACILITY HAS SPENT NUMEROUS HOURS BOTH IN-HOUSE, ON HOTLINE AND WITH THE FIELD SERVICE. ALSO FACILITY HAS SPENT VAST AMOUNTS OF MONEY IN REPLACING REAGENTS AND QC MATERIALS. IN 2003 FACILITY HAD A PROBLEM WITH A QC-REPLACED REAGENT AND A VIAL OF A QC WITH NO RESOLUTION. FACILITY REPLACED THE TUBING AND HEAT EXCHANGER WITH NO RESOLUTION. FACILITY TRIED A SECOND SET OF TUBING AND HEAT EXCHANGER FROM ANOTHER BOX (SAME LOT NUMBER) AND SAW VAST IMPROVEMENT. THE INSTRUMENT SPECIALIST SAYS TECHNICAL SUPPORT TOLD HIM THE COMPANY HAD CHANGED MANUFACTURERS. AS OF RIGHT NOW, THEY HAVE 4 LOT NUMBERS AVAILABLE AND HAVE RECEIVED OTHER COMPLAINTS ON THE LOT NUMBER FACILITY HAS BUT HAVE NOT PULLED IT FROM DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOLIANCE ELECTRA 1400C/1600C HEAT EXCHANGERS (SMOKE) AND TUBING DTR INSTRUMENTATION LABORATORY * 50143-1

    Patients

    Seq Age Sex Outcome Treatment
    1 *