BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC CENTRIMAG PRIMARY CONSOLE

    MDR report key: 3908378 · Received June 3, 2014

    Report

    Report Number
    2916596-2014-00920
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    February 24, 2014
    Report Date
    May 5, 2014
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED CONSOLE WAS CLEANED AND VISUALLY INSPECTED AND NO DAMGE WAS SEEN. THE RETURNED MOTOR (REF MFR REPORT #0002916596-2014-00450) WAS CONNECTED TO THE RETURNED CONSOLE AND FLOW PROBE AND ATTACHED TO A TEST LOOP FOR FUNCTIONAL TESTING. THE MOTOR AND FLOW PROBE FUNCTIONED AS INTENDED. THE REPORTED INCIDENT WAS CONFIRMED WHEN THE FLOW PROBE WAS ATTACHED AND A LOOSE CONTACT WAS PRODUCED BY DETACHING THE FLOW PROBE CONNECTOR. IN MOST CASES, THE CONSOLE ALARMED AUDIBLY AND VISUALLY AND THEN THE FLOW DISPLAY WENT DARK, BUT THE MOTOR CONTINUED TO OPERATE THE TEST PUMP. WHEN THE FLOW PROBE CONNECTOR'S POSITION WAS CHANGED, THE FLOW VALUE WAS DISPLAYED AGAIN AND THE ALARM WAS ABLE TO BE MUTED; HOWEVER, IN SOME CASES THE MOTOR IMMEDIATELY STOPPED WHEN THE LOOS FLOW PROBE CONTACT WAS SIMULATED AS DESCRIBED ABOVE. IN THESE CASES, THE CONSOLE CREATED AN AUDIBLE ALARM. AFTER SWITCHING THE CONSOLE OFF AND ON, IT WORKED AS INTENDED AGAIN. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS SUPPORTED WITH AN ACUTE BLOOD PUMP SYSTEM. IT WAS REPORTED THAT THE PUMP FLOW VALUES STOPPED DISPLAYING ON THE CONSOLE. THE HOSPITAL STAFF ALSO REPORTED THAT NO AUDIBLE AND VISUAL ALARMS WERE SEEN AND IT WAS UNKNOWN IF THE PUMP ACTUALLY STOPPED. THE PERFUSIONIST INSPECTED THE SYSTEM AND DURING THE MOVEMENT OF THE FLOW PROBE CONNECTOR, THE FLOW DISPLAY AND THE SPEED DISPLAY STOPPED; HOWEVER, IT WAS UNCONFIRMED IF THE PUMP STOPPED. THE PERFUSIONIST SWITCHED THE PATIENT TO A BACKUP CONSOLE AND NO EFFECTS TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324368 THORATEC CENTRIMAG PRIMARY CONSOLE DSQ THORATEC SWITZERLAND GMBH 201-90180

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention