BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6861802 · Received September 13, 2017

    Report

    Report Number
    3007042319-2017-03102
    Event Type
    Malfunction
    Date Received
    September 13, 2017
    Date of Event
    November 14, 2016
    Report Date
    November 14, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAC ADAPTER, (B)(4), WAS RETURNED FOR EVALUATION. THE CAC ADAPTER, (B)(4), WAS INITIALLY RECEIVED AS A NON-COMPLAINT DEVICE AND WAS SUBSEQUENTLY DISPOSED OF AND UNAVAILABLE FOR EVALUATION. A REVIEW OF THE (B)(4) MANUFACTURING DOCUMENTATION CONFIRMED THAT CAC MET ALL REQUIREMENTS FOR RELEASE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICE IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CAC ADAPTER (B)(4) REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING BUT FAILED VISUAL INSPECTION DUE TO A TEAR ON THE OUTPUT CABLE; THE CONTROLLER AC ADAPTER WAS STILL ABLE TO ADEQUATELY PROVIDE POWER TO A TEST CONTROLLER. THIS IS AN ADDITIONAL OBSERVATION NOT RELATED TO REPORTED EVENT AND LIKELY DUE TO WEAR OF THE OUTPUT CABLE OR TO THE HANDLING OF THE DEVICE. 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 CAC ADAPTER HAS CABLES THAT CONNECT TO THE CONTROLLER AND INTO AN ELECTRICAL OUTLET. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL INSTRUCT THE USER THAT A GREEN INDICATOR LIGHT ON THE ADAPTER WILL INDICATE PROPER CONNECTION. IF THE AC/DC INDICATOR DOESN'T TURN GREEN, THE CONTROLLER IS USING BATTERY POWER AND THE "POWER DISCONNECT" ALARM WILL SOUND. THE IFU CAUTIONS USERS TO NOT FORCE CONNECTORS TOGETHER WITHOUT PROPER ALIGNMENT. FORCING TOGETHER MISALIGNED CONNECTORS MAY DAMAGE THE CONNECTORS. USERS ARE INSTRUCTED TO RETURN ANY DAMAGED COMPONENTS TO THE MANUFACTURER. 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. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE VAD COORDINATOR THAT THE TWO CONTROLLER AC ADAPTERS WERE NOT PROVIDING POWER. THE ADAPTERS WERE REPLACED WITHOUT CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641504 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1