BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3820573 · Received April 11, 2014

    Report

    Report Number
    2916596-2014-00555
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT DURING PT CLINIC VISIT, UPON CHECKING THE CONTROLLER HISTORY, IT WAS NOTED THAT THE PT HAD A CLOCK RESET AND LOW FLOW, BUT THE PT REPORTED ON DRIVELINE DISCONNECTS, DID NOT CHANGE OUT CONTROLLER AND HAD NO AUDIBLE ALARMS. THE VAD COORDINATOR NOTED THAT THERE ARE SEVERAL KINKS IN THE DRIVELINE. COULD NOT INDUCE ANY ALARMS WHEN MANIPULATED. THE CONTROLLER WAS CHANGED. THE LOG FILE SHOWS THAT THE WHITE LEAD WAS ON BATTERY POWER AND THE BLACK LEAD WAS NOT CONNECTED TO ANYTHING JUST PRIOR TO THE LOSS OF POWER. IT IS POSSIBLE THAT WITHER THE BATTERY ON THE WHITE LEAD WAS TOO LOW TO RUNT HE PUMP INDEPENDENTLY OR BOTH LEADS BECAME DISCONNECTED BRIEFLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221563 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLELR DSQ THORATEC CORP 103696 123069

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention