BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 4173136 · Received October 10, 2014

    Report

    Report Number
    2916596-2014-01811
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION - THE SYSTEM CONTROLLER WAS NOT RETURNED. THE REPORTED LOW SPEED OPERATION AND POWER INTERRUPTION WERE CONFIRMED PER THE EVALUATION OF THE SUBMITTED LOG FILE. A SPECIFIC CAUSE FOR THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE DETERMINED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED FOR THE SYSTEM CONTROLLER BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE HOSP THAT THE PT EXPERIENCED TWO LOW FLOW ALARMS, ONE OF WHICH WAS ACCOMPANIED BY THE PUMP POWER GOING TO ZERO. THE PT STATED THAT HE HEARD THE PUMP OFF ALARM, BUT IT ONLY LASTED A FEW SECONDS. THE MFR'S TECHNICAL SERVICES REVIEWED THE EVENT HISTORY AND CONFIRMED SPEED DROPS AND PUMP STOPS CAUSED BY LOW OR NO VOLTAGE SUPPLY. THIS CAN BE AN INDICATION OF CABLE FATIGUE ON THE CONTROLLER POWER LEADS. TECHNICAL SERVICES ADVISED THAT A NEW CONTROLLER MAY BE NECESSARY AS WELL AS EXAMINATION OF THE PT CABLE, BATTERIES, AND BATTERY CLIPS FOR INTEGRITY. THE PT WAS ASYMPTOMATIC AT THE TIME OF EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION - IT WAS REPORTED THAT AT THE TIME OF THE EVENT, THE PATIENT'S SYSTEM CONTROLLER WAS EXCHANGED. NO FURTHER EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642698 HEARTMATE II SYSTEM CONTROLLER DSQ:LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 103696 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention