BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 3060926 · Received April 10, 2013

    Report

    Report Number
    1828100-2013-00384
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE BATTERIES WERE NOT HOLDING A CHARGE AND WERE IN THE YELLOW ZONE. THE DEVICE WAS NOT CHANGED OUT AS THIS CENTRIFUGAL SYSTEM WAS BEING USED AS A BACK-UP AND WOULD HAVE STILL OPERATED IF NEEDED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150055 TERUMO CENTRIFUGAL SYSTEM DWA TERUMO CARDIOVASCULAR SYSTEMS CORP. 9490

    Patients

    Seq Age Sex Outcome Treatment
    1