BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 2883217 · Received December 21, 2012

    Report

    Report Number
    3007042319-2012-00006
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 (3007042319-2012-00006 AND 2016-02036) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    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

    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.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A (B)(6), FEMALE, PATIENT, WITH AN UNKNOWN PAST MEDICAL HISTORY WHO EXPERIENCED A CONTROLLER ELECTRICAL FAULT ALARM POST HEARTWARE LVAD IMPLANTATION. THE PATIENT WAS IMPLANTED WITH AN LVAD ON (B)(6) 2012. APPROXIMATELY 42 DAYS AFTER THE IMPLANTATION, THE SITE CALLED TO REPORT OCCASIONAL ELECTRICAL FAULT ALARMS WITH THE PATIENT CONTROLLER (B)(4). THE PERFUSIONIST INSPECTED THE DRIVELINE FOR ANY WIRE EXPOSURE AND PAST SHEATH REPAIRS. NO WIRE EXPOSURE WAS NOTED, ONLY A SLIGHT CREAM COLORED DISCHARGE WAS OBSERVED ON CONNECTOR. THE DRIVELINE CONNECTOR WAS CLEANED ACCORDING TO PROCEDURES AND SECURED TO AVOID REOCCURRENCE. ADDITIONALLY, AN ELECTIVE CONTROLLER EXCHANGE WAS PERFORMED. THE PATIENT RECEIVED ANTI-ANXIETY MEDICATION, PLACED ON AN INOTROPE AND GIVEN A BOLUS OF HEPARIN DUE TO LOW INR. THE PROBLEM WAS SOLVED WITHOUT PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR