BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3242325 · Received July 23, 2013

    Report

    Report Number
    3007042319-2013-00118
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 24, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED IN THE FIELD BY HEARTWARE CLINICAL ENGINEERING PERSONNEL. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT, THEREFORE IT WILL NOT BE RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    HEARTWARE IS SUBMITTING THIS CORRECTION TO A PREVIOUSLY SUBMITTED MDR REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803.

    Additional Manufacturer Narrative · 1

    THE HVAD® PUMP (B)(4) WAS NOT RETURNED TO HEARTWARE. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT PUMP MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED DRIVELINE CONNECTOR DAMAGE EVENT WAS CONFIRMED VISUALLY AT THE SITE BY THE HEARTWARE CLINICAL ENGINEER WHO PERFORMED THE SERVICING PROCEDURE. ANALYSIS OF THE CONTROLLER LOG FILES FURTHER CORROBORATE THE REPORTED EVENT, SHOWING MULTIPLE " VAD STOPPED/VAD DISCONNECT " ALARMS AND AN " ELECTRICAL FAULT " ALARM AROUND THE TIME OF THE EVENT. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    Description of Event or Problem · 1

    APPROXIMATELY 3 MONTHS AFTER THE IMPLANTATION, THE SITE REPORTED THAT THE PATIENT EXPERIENCED ELECTRICAL FAULT ALARMS FOLLOWED BY A VAD STOP, WHICH WAS CONFIRMED VIA LOG FILES REVIEW. THE VAD COORDINATOR INSPECTED THE DRIVELINE CONNECTOR AND NOTICED THAT THE PINS WERE ALL RECESSED. A TEMPORARY DRIVELINE SPLICE REPAIR WAS PERFORMED BY THE VAD COORDINATOR AND THE PUMP WAS ABLE TO RE-START ON A SINGLE STATOR MODE. THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE THE HEARTWARE FIELD SERVICE ENGINEER PERFORMED A PUMP DRIVELINE SPLICE REPAIR. OF NOTE, HE USED A Y-CABLE IN ORDER TO REDUCE THE RISK OF PUMP RE-START FAILURE. THOUGH THE PATIENT WAS SYMPTOMATIC DURING THE SHORT PERIODS OF DRIVELINE DISCONNECT DURING THE PROCEDURE, NO PERMANENT PATIENT EFFECTS WERE REPORTED. POST-PROCEDURE, THE PATIENT WAS TRANSFERRED TO A REGULAR HOSPITAL WARD. AT SOME LATER POINT, THE PATIENT IS REPORTED TO HAVE EXPIRED. THE DATE AND CAUSE OF DEATH WERE NOT REPORTED; HOWEVER IT WAS NOTED THAT IT WAS NOT RELATED TO THE HEARTWARE DEVICE AND RELATED TO THE PATIENT¿S OVERALL POOR CONDITION. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343295 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1