BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 3240920 · Received July 17, 2013

    Report

    Report Number
    1828100-2013-00671
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 26, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PERFUSIONIST STATED HE THOUGHT IT COULD HAVE BEEN THE SURGICAL FIELD WHERE THE PROBLEM WAS BUT JUST TO BE CERTAIN HE WANTED MOTOR CHECKED OUT. EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE FLOW WAS IRREGULAR OF THE CENTRIFUGAL DRIVE MOTOR ON THE CENTRIFUGAL SYSTEM. THE DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332078 TERUMO CENTRIFUGAL SYSTEM DWA TERUMO CARDIOVASCULAR SYSTEM CORP 164267

    Patients

    Seq Age Sex Outcome Treatment
    1