BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 2950651 · Received February 8, 2013

    Report

    Report Number
    3007042319-2013-00011
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND THEREFORE, IS NOT AVAILABLE FOR RETURN TO HEARTWARE. CONTAMINATION OF THE HVAD DRIVELINE CONNECTOR WAS VISUALLY CONFIRMED BY THE HEARTWARE FIELD ENGINEER AND A CLEANING PROCEDURE WAS CONDUCTED PER PROCEDURE. THE CONTAMINATION WAS IDENTIFIED AS THE CAUSE OF THE ELECTRICAL FAULT ALARMS (CONTAMINATION AROUND THE PIN INSULATES IT AND RESULTS IN AN OPEN CONDITION, I.E. FRONT OPEN PHASE_C, RESULTING IN SINGLE STATOR OPERATION). THE CONTROLLER WAS ELECTIVELY EXCHANGED AS LEAVING IT IN PLACE COULD LEAD TO CROSS CONTAMINATION OF THE DRIVELINE CONNECTOR AGAIN, AND COULD RESULT IN PERMANENT DAMAGE TO THE PINS IF LEFT UNTREATED. THE CONTROLLER WAS RECEIVED BY HEARTWARE AND WAS TESTED. NO MALFUNCTIONS WERE FOUND (AS FOUND PREVIOUSLY IN OTHER SIMILAR COMPLAINTS). AN INTERNAL INVESTIGATION (CAPA) HAS IDENTIFIED THE ROOT CAUSE OF THE EVENT AS BEING DRIVELINE CONNECTOR CONTAMINATION AND A CLEANING PROCEDURE WAS IMPLEMENTED; HOWEVER, THE ROOT CAUSE OF THE CONTAMINATION ITSELF IS STILL UNCLEAR AND IS STILL UNDER INVESTIGATION. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    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. THIS IS ONE OF TWO REPORTS (3007042319-2013-00011 AND 2016-02037) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT WHO EXPERIENCED FOREIGN MATERIAL IN THE DRIVELINE CONNECTOR APPROXIMATELY 21 DAYS POST HEARTWARE LVAD IMPLANTATION. THE SITE CALLED TO REPORT OCCASIONAL ELECTRICAL FAULT ALARMS WITH THE PATIENT CONTROLLER. VAD COORDINATOR INSPECTED THE DRIVELINE. NO WIRE EXPOSURE WAS NOTED, ONLY A SLIGHT DISCOLORATION ON CONNECTOR WAS OBSERVED. A SCHEDULED DRIVELINE CLEANING PROCEDURE AND ELECTIVE CONTROLLER EXCHANGE WAS PERFORMED BY A HEARTWARE FIELD CLINICAL ENGINEER WITHOUT PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55148 HEARTWARE® VENTRICULAR ASSIST SYSTEM HEARTWARE® VENTRICULAR ASSIST SYSTEM, DRIVELINE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1