BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2052135 · Received March 1, 2011

    Report

    Report Number
    2916596-2011-00087
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 9, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF THE SYSTEM CONTROLLER ALARMING WAS CONFIRMED AND REPRODUCED DURING ANALYSIS. THE BLACK POWER CABLE HAD MULTIPLE INNER CONDUCTORS THAT WERE COMPROMISED INCLUDING THE YELLOW (ALARM OUT) THAT WOULD CAUSE THE POWER MODULE TO ALARM UPON MOVEMENT. THE PUMP CONTINUED TO FUNCTION WITHOUT ANY INTERRUPTION OR SPEED REDUCTIONS DURING ANALYSIS. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS SYSTEM CONTROLLER SHOWED NO DEVIATIONS FROM MFG OR QA SPECIFICATIONS. THIS SITUATION IS BEING ADDRESSED THROUGH THE MFR'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/10001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE SYSTEM CONTROLLER WAS ALARMING. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE EVENT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 92646

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other