BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 4293299 · Received November 21, 2014

    Report

    Report Number
    1828100-2014-00991
    Event Type
    Malfunction
    Date Received
    November 21, 2014
    Date of Event
    October 30, 2014
    Report Date
    October 30, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THE PERFUSIONIST (CCP) WAS CHECKING THE UNIT WHEN THEY FOUND THE ISSUE. THERE WAS NO PT INVOLVED. THIS UNIT IS PRIMARILY USED AS BACK-UP. THE FIELD SERVICE REP PERFORMED PREVENTIVE MAINTENANCE (PM) INSPECTION AND CONFIRMED THE BATTERIES WERE NOT HOLDING A CHARGE. HE REPLACED THE BATTERIES AND COMPLETED A RELEASE TEST. THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT BATTERIES WERE RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USER OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE DELPHIN PUMPS USED AS BACKUP FOR THEIR SYSTEM-1'S WERE NOT HOLDING A BATTERY CHARGE IN THE CENTRIFUGAL SYSTEM. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758537 TERUMO CENTRIFUGAL SYSTEM SARNS CARDIOVASCULAR SYSTEM CORP DWA TERUMO CARDIOVASCULAR SYSTEM CORP 6379

    Patients

    Seq Age Sex Outcome Treatment
    1