BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6793192 · Received August 14, 2017

    Report

    Report Number
    3007042319-2017-02652
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    September 5, 2016
    Report Date
    September 6, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATTERY WAS RETURNED FOR ANALYSIS. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. ANALYSIS REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. THE TIME IT TOOK TO DISCHARGE THE BATTERY TO 12 V AT 1 A WAS 4 HOURS AND 5 MINUTES. THIS IS COMPARABLE TO THE DISCHARGE RATE OF OTHER WORKING BATTERIES. THE REPORTED EVENT COULD NOT BE DUPLICATED AT THE BENCH LEVEL. PER THE INSTRUCTIONS FOR USE (IFU): THE HVAD CONTROLLER REQUIRES TWO POWER SOURCES FOR SAFE OPERATION: EITHER TWO BATTERIES, OR ONE BATTERY AND AN AC ADAPTER OR DC ADAPTER. 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. THE IFU AND PATIENT MANUAL ALSO INCLUDE 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. USERS ARE INSTRUCTED TO RETURN ANY DAMAGED COMPONENTS TO THE MANUFACTURER. USERS ARE CAUTIONED TO CHARGE DEPLETED BATTERIES WITHIN 24 HOURS TO AVOID PERMANENT BATTERY DAMAGE AND TO STORE BATTERIES AT ROOM TEMPERATURE. 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

    A REPORT WAS RECEIVED THAT THE BATTERY WAS PROVIDING POWER FOR LESS THAN TWO HOURS. THE BATTERY WAS REPLACED WITH NO REPORTED PATIENT CONSEQUENCE. THE BATTERY DID NOT SWITCH TO THE OTHER POWER PORT BEFORE THE BATTERY CAPACITY DISPLAY REACHED ONE RED BAR ON THE CONTROLLER. THE PATIENT DID NOT HAVE A HISTORY OF CHARGING THE BATTERY BEFORE IT WAS FULLY DEPLETED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572080 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1