BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 5291686 · Received December 11, 2015

    Report

    Report Number
    2916596-2015-02353
    Event Type
    Malfunction
    Date Received
    December 11, 2015
    Date of Event
    November 12, 2015
    Report Date
    November 14, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE - 9 MONTHS. THE REPORTED PUMP STOPPAGE WAS OBSERVED IN THE SUBMITTED SYSTEM CONTROLLER LOG FILE. THE LOG FILE SHOWED THAT THE PUMP APPEARED TO BE OPERATING NORMALLY UNTIL TIMESTAMP (B)(6) 2015 22:45, WHEN A LOW BATTERY HAZARD ALARM BECAME ACTIVE AND THE SYSTEM WENT INTO POWER SAVE MODE. THE NEXT RECORDED EVENT AT (B)(6) 2015 22:53 SHOWED A LOW BATTERY HAZARD ALARM WITH THE POWER CABLE VOLTAGES AT ZERO. WHEN POWER WAS RESTORED, A CLOCK RESET EVENT OCCURRED WITH THE TIMESTAMP AT (B)(6) 2001 1:00 AND THE PUMP SPEED AT 0 RPM WITH LOW BATTERY HAZARD, LOW FLOW HAZARD, AND BACKUP BATTERY UNINSTALLED ALARMS ACTIVE. THESE EVENTS ARE INDICATIVE OF A LOSS OF POWER TO THE SYSTEM CONTROLLER DUE TO DEPLETED BATTERIES. THE EVALUATION OF THE LOG FILE COULD NOT DETERMINE HOW LONG THE SYSTEM WAS WITHOUT POWER. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. 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. DURING REVIEW OF THE PATIENT'S EVENT HISTORY, A PUMP STOPPAGE EVENT WAS OBSERVED. THE SUBMITTED LOG FILE WAS REVIEWED BY THE MANUFACTURER'S TECHNICAL SERVICES REPRESENTATIVE AND REVEALED LOW BATTERY HAZARD ALARMS WITH SUBSEQUENT DEPLETION OF EXTERNAL BATTERIES. THE PATIENT REMAINED SUPPORTED ON THE BACKUP BATTERY UNTIL DEPLETION, WHEN THE PUMP STOPPED. THERE WAS NO INDICATION AS TO HOW LONG THE PUMP WAS OFF. THE SYSTEM CONTROLLER WAS RECONNECTED TO THE POWER MODULE AT AN UNDETERMINED POINT IN TIME AND PUMP OPERATION RESUMED. IT WAS REPORTED THAT THE PUMP STOPPAGE WAS DUE TO THE PATIENT FALLING ASLEEP WHILE CONNECTED TO BATTERIES AND EVENTUALLY DEPLETING THE BACKUP BATTERY. THE PUMP REMAINS IN USE AND NO FURTHER ALARMS WERE REPORTED. NO PATIENT IMPACT DUE TO THE PUMP STOPPAGE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820263 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR