BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER AC ADAPTER

    MDR report key: 7112260 · Received December 13, 2017

    Report

    Report Number
    3007042319-2017-04805
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    August 16, 2015
    Report Date
    December 13, 2017
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: IT WAS REPORTED THAT THE CONTROLLER AC (CAC) ADAPTER WAS UNABLE TO PROVIDE POWER. ONE 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. FAILURE ANALYSIS OF THE DEVICE REVEALED THAT THE UNIT PASSED VISUAL INSPECTION BUT FAILED FUNCTIONAL TESTING DUE TO AN OPEN INPUT FUSE. THE OPEN FUSE PREVENTED THE CONTROLLER AC ADAPTER FROM PROVIDING POWER, CONFIRMING THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO AN OPEN FUSE, DUE TO A COMBINATION OF A REDUCED FUSE IN-RUSH CURRENT RATING ALONG WITH THE ABSENCE OF A CURRENT-LIMITING THERMISTOR. AN INTERNAL INVESTIGATION WAS OPENED TO INVESTIGATE INPUT FUSES ASSOCIATED WITH CONTROLLER AC ADAPTERS, CATALOG NUMBER 1430XX. 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. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONTROLLER DID NOT RECOGNIZE THE CONNECTION OF THE CONTROLLER AC (CAC) ADAPTER AS AN ENERGY SOURCE, AND GAVE THE RESPECTIVE ACOUSTICAL SIGNAL. IT WAS ALSO REPORTED THAT THERE WAS NO LIGHT EMITTING DIODE (LED) LIGHT ON THE CAC ADAPTER. THE CAC ADAPTER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893610 HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER AC ADAPTER VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1430DE

    Patients

    Seq Age Sex Outcome Treatment
    1