BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 1052473 · Received May 22, 2008

    Report

    Report Number
    1828100-2008-00276
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 22, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE FOR CARDIOPULMONARY BYPASS, THE CENTRIFUGAL PUMP BATTERY INDICATOR LED WAS ILLUMINATED UNEXPECTEDLY EVEN THOUGH THE DEVICE WAS NOT CONNECTED TO THE BATTERY. THE DEVICE WAS REPLACED WITH AN ALTERNATE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CENTRIFUGAL SYSTEM CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. 6379

    Patients

    Seq Age Sex Outcome Treatment
    1