BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER DC ADAPTER

    MDR report key: 7150425 · Received December 28, 2017

    Report

    Report Number
    3007042319-2017-05479
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Date of Event
    December 7, 2015
    Report Date
    December 27, 2017
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000109
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: IT WAS REPORTED THE CONTROLLER DC ADAPTER WOULD NO LONGER PROVIDE POWER TO THE CONTROLLER. THE CONTROLLER DC ADAPTER WAS RETURNED FOR EVALUATION. THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS INITIALLY RETURNED TO THE PRODUCT ANALYSIS LAB ON 12/121/2015, BUT REMAINS UNACCOUNTED FOR. AN INVESTIGATION WAS OPENED TO DETERMINE THE WHEREABOUTS OF THE DEVICE. AS A RESULT, THE REPORTED EVENT COULD NOT BE CONFIRMED BECAUSE THE DEVICE IS UNAVAILABLE FOR ANALYSIS. A REVIEW OF DOCUMENTATION RECORDS CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS SIMILAR CIRCUMSTANCES WERE CONSIDERED. A POSSIBLE ROOT CAUSE OF THE INABILITY OF THE CONTROLLER DC ADAPTER TO PROVIDE POWER MAY BE ATTRIBUTED, BUT NOT LIMITED TO AN OPEN CIRCUIT ALONG THE OUTPUT CABLE OR OUTPUT CONNECTOR. 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 DC ADAPTER WAS NO LONGER PROVIDING POWER TO THE CONTROLLER. THE CONTROLLER DC ADAPTER WAS TAKEN OUT OF SERVICE AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932233 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER DC ADAPTER VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1435- 00888707000109

    Patients

    Seq Age Sex Outcome Treatment
    1