BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 2883192 · Received December 21, 2012

    Report

    Report Number
    3007042319-2012-00004
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 29, 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

    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 PATIENT OF UNKNOWN AGE AND GENDER WITH AN UNKNOWN PAST MEDICAL HISTORY WHO EXPERIENCED A CONTROLLER E-FAULT ALARM POST HEARTWARE LVAD IMPLANTATION. THE PATIENT WAS IMPLANTED WITH AN LVAD ON (B)(6) 2012. APPROXIMATELY 17 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 DISCOLORATION ON CONNECTOR AND BOOT WAS OBSERVED. A DRIVELINE CLEANING PROCEDURE AND ELECTIVE CONTROLLER EXCHANGE WERE PERFORMED. OF NOTE, THE PATIENT WAS GIVEN SEDATION DURING THE CLEANING PROCEDURE FOR PERCEIVED ANXIETY. 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 CONTROLLER ((B)(4))