BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 4253224 · Received November 13, 2014

    Report

    Report Number
    2916596-2014-02080
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    August 18, 2014
    Report Date
    October 15, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE REPORTED INCIDENT OF A DAMAGED BLACK POWER LEAD WAS CONFIRMED DURING VISUAL EXAMINATION. DURING ANALYSIS, THE DEVICE DID NOT PASS THE INSULATION HI-POT TESTING, WHICH INDICATED COMPROMISED UNDERLYING WIRES. MANIPULATION OF THE DAMAGED AREA RESULTED IN AN INTERRUPTION OF THE PUMP SPEED. VISUAL INSPECTION OF THE UNDERLYING WIRES REVEALED THE MECHANICAL INDUCED STRESS RESULTED IN THE SHIELDING TO PUNCTURE THE INSULATION, CAUSING A SHORT CIRCUIT CONDITION. THE LOG FILE RETRIEVED FROM THE SYSTEM CONTROLLER WAS REVIEWED AND CAPTURED MOTOR STOPPED EVENTS WITH ASSOCIATED LOW FLOW HAZARD (RED HEART) ALARMS. THE EVENTS WERE CAPTURED WHILE CONNECTED TO THE POWER MODULE CONSISTENT WITH THE ANALYSIS FINDINGS. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE SYSTEM CONTROLLER MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE BEND RELIEF ON THE BLACK POWER LEAD OF THE SYSTEM CONTROLLER WAS DAMAGED. THE VAD COORDINATOR WAS UNABLE TO DOWNLOAD THE LOG FILE FROM THE SYSTEM CONTROLLER. THE SYSTEM CONTROLLER WAS EXCHANGED. DURING THE INVESTIGATION, DAMAGE TO THE BLACK POWER LEAD OF THE SYSTEM CONTROLLER WAS FOUND AND WHEN MANIPULATED PUMP STOPPAGE OCCURRED. PUMP STOPPAGE WAS ALSO NOTED IN THE LOG FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732592 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR