BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6906013 · Received September 29, 2017

    Report

    Report Number
    3007042319-2017-03455
    Event Type
    Malfunction
    Date Received
    September 29, 2017
    Date of Event
    February 8, 2016
    Report Date
    February 8, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. THE REPORTED EVENT WAS CONFIRMED VIA VISUAL INSPECTION. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE FAILED TO MEET SPECIFICATIONS; THE DEVICE FAILED VISUAL INSPECTION DUE TO A TEAR IN THE CAC ADAPTER'S CABLE, EXPOSING THE WIRING WITHIN. THE CONFIRMED MALFUNCTION IS RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MISHANDLING OF THE CAC ADAPTER'S CABLE. 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 A PATIENT EXPERIENCED A CAC ADAPTER WITH A DAMAGED CABLE. THE PATIENT DENIES USING ANY EXCESSIVE FORCE TO THE ADAPTER. THE DEVICE WAS REPLACED WITH NO NOTED CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685383 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR