BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4810140 · Received June 2, 2015

    Report

    Report Number
    2916596-2015-00994
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    April 14, 2015
    Report Date
    May 4, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 1 YEAR AND 2 MONTHS. THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. THE REPORT OF THE PUMP STOPPING DUE TO DEPLETED BATTERIES COULD NOT BE CONFIRMED BECAUSE NO LOG FILES ARE AVAILABLE; HOWEVER, IT WAS REPORTED THAT THE EVENT WAS DUE TO THE PATIENT BEING NON-COMPLIANT AND THAT IT WAS NOT DEVICE RELATED. THE PATIENT WAS OPERATING ON BATTERY POWER, AND THE BATTERIES APPROPRIATELY RAN OUT OF CHARGE. THE SYSTEM ALARMED WITH A RED HEART ALARM. THE PATIENT DID NOT CHANGE THE BATTERIES, AND THE PUMP WAS REPORTEDLY OFF FOR APPROXIMATELY 12 HOURS. THE PATIENT REMAINED ASYMPTOMATIC, AND THERE WERE NO ISSUES WITH THE PUMP RESTARTING. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT DID NOT CHANGE THE BATTERIES WHILE ON BATTERY POWER AND THEY APPROPRIATELY RAN OUT OF CHARGE. THE PUMP WAS REPORTEDLY OFF FOR 12 HOURS (THE SYSTEM ALARMED RED HEART WITH A CONSTANT TONE). THE PATIENT REMAINED ASYMPTOMATIC AND THERE WERE NO ISSUES WITH THE PUMP RESTARTING AND NO REPORTED ISSUES SINCE THIS EVENT. IT WAS REPORTED THAT THE EVENT WAS NOT PRODUCT RELATED BUT RATHER THE PATIENT WAS NON-COMPLIANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354120 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR