BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6287458 · Received January 30, 2017

    Report

    Report Number
    3007042319-2017-00287
    Event Type
    Malfunction
    Date Received
    January 30, 2017
    Date of Event
    January 3, 2017
    Report Date
    January 9, 2017
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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. THE "CONTROLLER FAILED" ALARM INDICATES A POTENTIAL CONTROLLER FAILURE; THE CONTROLLER SHOULD BE EXCHANGED WITH THE BACK-UP CONTROLLER. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ALARM ON HER VAD THAT SAID, "CONTROLLER FAILED." THE CONTROLLER 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. LOG FILE ANALYSIS DID NOT REVEAL A CONTROLLER FAILED ALARM IN THE ALARM FILES. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE MET SPECIFICATIONS; THE DEVICE PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. THE REPORTED EVENT COULD NOT BE CONFIRMED; A CONTROLLER FAILED ALARM WAS NOT RECORDED IN THE LOG FILES OR DUPLICATED DURING TESTING. WITH REVIEW OF THE REPORTED INFORMATION AND ANALYSIS OF THE RETURNED DEVICE WITH NO CONFIRMED MALFUNCTION, A ROOT CAUSE CANNOT BE DETERMINED. 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 BY THE MCS COORDINATOR THAT THE PATIENT HAD AN ALARM ON HER VAD THAT SAID "CONTROLLER FAILED."  THE CONTROLLER WAS CHANGED TO THE BACKUP CONTROLLER. THE PATIENT TOLERATED THE EXCHANGE WELL WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68809 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1