BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER AC ADAPTER

    MDR report key: 7130399 · Received December 19, 2017

    Report

    Report Number
    3007042319-2017-05235
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    April 22, 2015
    Report Date
    December 19, 2017
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: A CONTROLLER AC (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. THE REPORTED EVENT WAS CONFIRMED VIA FUNCTIONAL TESTING. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE FAILED TO MEET SPECIFICATIONS; THE DEVICE FAILED VISUAL INSPECTION AND FUNCTIONAL TESTING DUE TO A CRACK ON THE HOUSING AND TWO OPEN WIRES INSIDE THE CORD. THE CONFIRMED MALFUNCTION IS RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO WEAR ON THE STRAIN RELIEF AS A RESULT OF EXCESSIVE BENDING. THE USAGE PATTERN MOST LIKELY CONTRIBUTED TO THE FRAYING OR BREAKING OF THE CABLE WIRE. ANOTHER POSSIBLE ROOT CAUSE COULD BE THE DAMAGED CASE, AS A RESULT OF THE CAC BEING DROPPED OR HIT FORCEFULLY DURING USE. 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 THERE WAS TROUBLE WITH THE CONTROLLER AC (CAC) ADAPTER. WHEN THE PATIENT PLUGGED THE CAC IN AT NIGHT, IT WOULD BEEP AND SWITCH TO THE BATTERY. THE CAC WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910407 HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER AC ADAPTER VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1425US

    Patients

    Seq Age Sex Outcome Treatment
    1