BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 1181047 · Received September 29, 2008

    Report

    Report Number
    1828100-2008-00450
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 29, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K902198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    DURING USE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE PUMP SYSTEM DISPLAYED EVIDENCE THAT THE STATUS OF THE BACKUP BATTERY COULD NOT BE RELIABLY DETERMINED. AN ALTERNATIVE DEVICE WAS EMPLOYED, AND THE PROCEDURE CONCLUDED WITHOUT INCIDENT. THERE WERE NO REPORTED CONSEQUENCES 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 BATTERY MODULE KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. 9490

    Patients

    Seq Age Sex Outcome Treatment
    1