BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6816642 · Received August 24, 2017

    Report

    Report Number
    3007042319-2017-02820
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    July 28, 2017
    Report Date
    November 10, 2017
    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

    PRODUCT EVENT SUMMARY: IT WAS REPORTED LOOSE POWER PORTS ON CONTROLLER (B)(4). TWO CONTROLLERS ((B)(4)) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. REVIEW OF THE (B)(4) MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. FAILURE ANALYSIS OF THE RETURNED (B)(4) REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING AND VISUAL INSPECTION. FAILURE ANALYSIS OF THE RETURNED (B)(4) REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING BUT FAILED VISUAL INSPECTION DUE TO A LOOSE POWER PORT 1 CONNECTOR. AN INTERNAL INSPECTION OF THE CONTROLLER DID NOT REVEAL FOREIGN MATERIAL. BASED ON AN INVESTIGATION CONDUCTED, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO INADEQUATE THREAD LOCK, AN INCONSISTENT THREAD LOCK CURE TIME AND AN INADEQUATE TORQUE APPLICATION DURING THE ASSEMBLY PROCESS. CONTROLLER 210626, DEVICE AVAILABLE FOR EVALUATION: YES, RETURN DATE: 2017-09-19, DEVICE EVALUATED BY MFR: YES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES FOR THIS COMPLAINTS: CIRCULATORY ASSIST SYSTEM - CONTROLLER (B)(4) - CONTROLLER / CATALOG NUMBER 1407DE / EXPIRATION DATE 01/31/2017 (B)(4), NOT RETURNED TO MANUFACTURER. (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TWO CONTROLLERS HAD LOOSE POWER PORTS. THE CONTROLLERS WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597820 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM - CONTROLLER DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1