BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - CAC ADAPTER

    MDR report key: 6933223 · Received October 9, 2017

    Report

    Report Number
    3007042319-2017-03641
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    January 17, 2016
    Report Date
    January 19, 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

    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. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE FAILED TO MEET SPECIFICATIONS; THE DEVICE PASSED FUNCTIONAL TESTING BUT FAILED VISUAL INSPECTION AS A RESULT OF A TEAR IN THE CAC ADAPTER CABLE. THE CONFIRMED MALFUNCTION IS RELATED TO THE REPORTED EVENT; HOWEVER, THE CAC CABLE WAS ABLE TO PROVIDE POWER. 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. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR VISUAL ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF BATTERIES ARE OUTLINED. 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAC SHOWS A CRACK IN CABLE. POWER NO LONGER WORKS. THE DEVICE WAS REMOVED FROM SERVICE. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709336 HEARTWARE® VENTRICULAR ASSIST SYSTEM - CAC ADAPTER CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR