BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6356016 · Received February 24, 2017

    Report

    Report Number
    3007042319-2017-00533
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    October 11, 2016
    Report Date
    October 12, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    UDI-DI
    00888707000376
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE BATTERY WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. THE REPORTED EVENT (BATTERY NOT HOLDING A CHARGE) WAS NOT CONFIRMED AT THE BENCH SINCE THIS BATTERY WAS ABLE TO CHARGE AND DISCHARGE AS INTENDED. HOWEVER, LOG FILES REVEALED POTENTIAL EVENTS OF PREMATURE POWER SWITCHING INVOLVING THIS BATTERY. THESE PREMATURE SWITCHING EVENTS ARE MOST LIKELY DUE TO COMMUNICATION ANOMALIES BETWEEN BATTERY AND CONTROLLER OR NORMAL PATIENT USAGE BEHAVIOR AND IS NOT RELATED TO THE REPORTED EVENT. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE MET SPECIFICATIONS; THE DEVICE PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. NO FAILURE DETECTED, THE REPORTED EVENT COULD NOT BE DUPLICATED AT THE BENCH LEVEL. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF BATTERIES AND CONTROLLERS ARE OUTLINED. IT FURTHER WARNS THAT DAMAGED EQUIPMENT SHOULD BE REPORTED TO THE MANUFACTURER AND INSPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE VAD COORDINATOR THAT THIS PATIENT COMPLAINED THAT THE BATTERY WAS NOT HOLDING A CHARGE. THE BATTERY WAS EXCHANGED WITH NO CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139512 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC 00888707000376

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR