BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG MOTOR

    MDR report key: 4168429 · Received October 7, 2014

    Report

    Report Number
    2916596-2014-01750
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 9, 2014
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED AT (B)(6). THE PT'S AGE AND WEIGHT WERE NOT REPORTED TO THE MFR. THE RETURNED MOTOR WAS CLEANED AND VISUALLY INSPECTED, AND NO DAMAGE WAS SEEN. THE MOTOR WAS CONNECTED TO A TEST PRIMARY CONSOLE AND FLOW PROBE AND ATTACHED TO A TEST LOOP FOR FUNCTIONAL TESTING AND INVESTIGATION. DURING THE INITIAL STARTUP, THE MOTOR FUNCTIONED NORMALLY; HOWEVER, WHEN THE MOTOR'S CABLE WAS BENT A RATTLING NOISE WAS HEARD FROM THE PUMP HEAD. FURTHER EVALUATION OF THE MOTOR FOUND DAMAGE WITHIN THE MOTOR'S CABLE. A REVIEW OF DEVICE HISTORY RECORDS SHOWED ON DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. NO FURTHER INFO IS AVAILABLE AT THIS TIME. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS SUPPORTED WITH AN ACUTE BLOOD PUMP SYSTEM. IT WAS REPORTED WHEN CABLE ON THE MOTOR WAS MOVED; THE PUMP HEAD MADE A 'CLICKING NOISE AND THEN THE IMPELLER STALLED. "WHEN THE CABLE WAS MOVED TO ITS ORIGINAL POSITION THE MOTOR FUNCTIONED NORMALLY. THE HOSPITAL REPLACED THE MOTOR AND NO EFFECTS TO THE PT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626242 CENTRIMAG MOTOR CENTRIMAG MOTOR KFM THORATEC SWITZERLAND GMBH 201-10002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other