BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 6814330 · Received August 23, 2017

    Report

    Report Number
    3007042319-2017-02799
    Event Type
    Malfunction
    Date Received
    August 23, 2017
    Date of Event
    July 29, 2016
    Report Date
    August 2, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAC ADAPTER 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 CAC ADAPTER FAILED VISUAL INSPECTION AND PASSED FUNCTIONAL TESTING. THE CAC ADAPTER WAS RECEIVED WITHOUT THE HARDWARE TO FIRMLY SECURE IT TO THE AC MAIN POWER LINE. THIS OBSERVATION IS NOT RELATED TO THE REPORTED EVENT. THE REPORTED EVENT COULD NOT BE DUPLICATED AT THE BENCH LEVEL, THE CAC ADAPTER WAS ABLE TO PROVIDE POWER AS INTENDED.. PER THE INSTRUCTIONS FOR USE (IFU): ALWAYS KEEP A SPARE CONTROLLER AND FULLY CHARGED SPARE BATTERIES AVAILABLE AT ALL TIMES IN CASE OF AN EMERGENCY, BEYOND THE TWO (2) POWER SOURCES THAT ARE CURRENTLY CONNECTED TO THE CONTROLLER. INVESTIGATE, AND IF POSSIBLE, CORRECT THE CAUSE OF ANY ALARM. SILENCING AN ALARM DOES NOT RESOLVE THE ALARM CONDITION. DO NOT ATTACH THE ALARM ADAPTER TO A CONTROLLER CONNECTED TO THE RUNNING PUMP. THE ALARM ADAPTER SILENCES THE "NO POWER" ALARM AND SHOULD ONLY BE ATTACHED TO A CONTROLLER THAT HAS FAILED OR MALFUNCTIONED AND IS NO LONGER CONNECTED TO A PUMP. DO NOT DISCONNECT THE DRIVELINE FROM THE CONTROLLER OR THE PUMP WILL STOP. IF THIS HAPPENS, RECONNECT THE DRIVELINE TO THE CONTROLLER AS SOON AS POSSIBLE TO RESTART THE PUMP. 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF EVENTS, WHICH WAS IN RESPONSE TO AN UPDATE TO THE MDR DECISION CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAC ADAPTER LED INDICATOR WAS NOT WORKING WHEN CAC ADAPTER WAS CONNECTED TO THE WALL POWER. THE CAC ADAPTER NOT PROVIDING POWER TO CONTROLLER. THE CAC ADAPTER WAS EXCHANGED. NO EFFECT ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594796 HEARTWARE VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR