BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6444266 · Received March 29, 2017

    Report

    Report Number
    3007042319-2017-00891
    Event Type
    Malfunction
    Date Received
    March 29, 2017
    Date of Event
    February 5, 2017
    Report Date
    February 5, 2017
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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. FAILURE ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE CONTROLLER AC ADAPTER PASSED VISUAL EXAMINATION BUT FAILED FUNCTIONAL TESTING DUE TO AN INTERMITTENT CONNECTION WITHIN ONE OF THE WIRES OF THE CABLE THAT PROVIDES DC POWER. AS A RESULT, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO WEAR ON THE DEVICE CABLE AS A RESULT OF EXCESSIVE BENDING. THE USAGE PATTERN MOST LIKELY CONTRIBUTED TO THE FRAYING OR BREAKING OF THE CABLE WIRE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    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. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF BATTERIES AND CONTROLLERS ARE OUTLINED. 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 CONTROLLER AC ADAPTER (CAC) HAD THE GREEN LIGHT ILLUMINATED ON THE "BRICK" OF CAC BUT WAS NOT PROVIDING POWER TO THE PATIENTS CONTROLLER. THE PATIENT WAS BROUGHT IN AND THE APPROPRIATE TROUBLE SHOOTING WAS PERFORMED BY TRYING IT ON BOTH POWER PORTS AND DIFFERENT CACS. THE CAC WAS REPLACED. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226384 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1