BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BM14 FLUID UF MODULE FOR BM25

    MDR report key: 2136889 · Received June 22, 2011

    Report

    Report Number
    1423500-2011-08137
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 11, 2011
    Manufacturer
    EDWARDS LIFESCIENCES GERMANY GMBH
    Product Code
    FIR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE ACTUAL INSTRUMENT WAS RECEIVED, EVALUATED AND REPAIRED. THE ROOT CAUSE WAS THE POWER SUPPLY BOARD (230 VOLTS). TRANSPORTATION CAUSED SEVERAL CONDENSERS AND DIODES TO LOOSEN, RESULTING IN VOLTAGE FLUCTUATIONS AND SPARKING. THUS, IT WAS NOT POSSIBLE TO ESTABLISH CORRECT COMMUNICATION WITH BM14. THIS, IN TURN, CAUSED THE BM14 TO SWITCH OFF AGAIN, SINCE IT IS CONTROLLED VIA THE BM11.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER THAT AFTER INITIAL START UP OF THE BM25, THE BM14 SHUT OFF AFTER 30 SEC. THE INSTRUMENT COULD NOT BE USED FOR THE PATIENT TREATMENT. NO PATIENT INVOLVEMENT. THE INSTRUMENT WILL BE RETURNED FOR INVESTIGATION/REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BM14 FLUID UF MODULE FOR BM25 PUMP, BLOOD, EXTRA-LUMINAL FIR EDWARDS LIFESCIENCES GERMANY GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1