BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 4102291 · Received September 17, 2014

    Report

    Report Number
    2916596-2014-01656
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S EVENT HISTORY FROM THE RETURNED SYSTEM CONTROLLER WAS REVIEWED WHICH CONTAINED APPROXIMATELY 4 DAYS OF DATA. A PUMP STOPPAGE WAS RECORDED ACCOMPANIED BY A LOW SPEED HAZARD ALARM; HOWEVER, THE ALARM APPEARED TO BE BRIEF AS THE LOW FLOW ALARM DID NOT ACTIVATE AND ADDITIONAL EVENTS WERE RECORDED AT THE SAME TIME STAMP WHERE THE PUMP SPEED WAS BACK AT OPERATING RANGE. THE RETURNED SYSTEM CONTROLLER WAS FUNCTIONALLY TESTED WITH THE MANUFACTURER¿S TEST EQUIPMENT AND THE SYSTEM CONTROLLER OPERATED AS INTENDED. THE BLACK AND WHITE POWER CABLES WERE MANIPULATED WITH NO EFFECT AND BOTH POWER CABLES WERE INDEPENDENTLY DISCONNECTED AND THE SYSTEM FUNCTIONED AS EXPECTED SUPPORTED SOLELY BY EITHER CABLE. A CAUSE FOR THE EVENTS RECORDED IN THE PATIENT¿S EVENT HISTORY COULD NOT BE DETERMINED. 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 IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROX 4 MONTHS POST-IMPLANT, IT WAS REPORTED THAT DURING A ROUTINE HOSPITAL VISIT THE PATIENT'S EVENT HISTORY WAS REVIEWED AND INDICATED A PUMP STOPPAGE. THE PATIENT'S SYSTEM CONTROLLER WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576773 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 106017 136682

    Patients

    Seq Age Sex Outcome Treatment
    1 Other