BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - DC ADAPTOR

    MDR report key: 7120668 · Received December 15, 2017

    Report

    Report Number
    3007042319-2017-04954
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    November 21, 2014
    Report Date
    December 15, 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 ADAPTERS WERE UNABLE TO CONSISTENTLY POWER THE CONTROLLER. TWO CONTROLLER AC ADAPTERS AND ONE CONTROLLER DC ADAPTER WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE DEVICES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. AS A RESULT, THE REPORTED EVENT COULD NOT BE CONFIRMED; THE ADAPTERS WERE ABLE TO PERFORM AS INTENDED DURING BENCH TESTING AND DID NOT ALARM A POWER DISCONNECT ALARM WHEN CONNECTED TO A CONTROLLER. 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. OTHER DEVICES INVOLVED IN THE EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM - CAC ADAPTOR, CAC ADAPTOR / (B)(4) / MODEL #: 1430DE / EXPIRATION DATE: N/A UDI#: N/A, RETURN DATE: 2015-01-23, MFG DATE: N/A; HEARTWARE VENTRICULAR ASSIST SYSTEM - CAC ADAPTOR, CAC ADAPTOR / (B)(4) / MODEL #: 1430DE / EXPIRATION DATE: N/A UDI#: N/A, RETURN DATE: 2015-01-23, MFG DATE: N/A. 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 DISPLAYED MULTIPLE POWER DISCONNECTION ALARMS ALTHOUGH THE AC AND DC ADAPTORS WERE CONNECTED. A DC ADAPTOR AND TWO AC ADAPTORS WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900354 HEARTWARE VENTRICULAR ASSIST SYSTEM - DC ADAPTOR VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1440

    Patients

    Seq Age Sex Outcome Treatment
    1