BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3910278 · Received July 2, 2014

    Report

    Report Number
    3007042319-2013-00676
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ELECTRICAL FAULT ALARMS AND WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND LOG FILE RETRIEVAL. A MANUFACTURER REPRESENTATIVE PERFORMED A DRIVELINE CONNECTOR CLEANING PROCEDURE AND SUBSEQUENTLY CHANGED THE PATIENT'S CONTROLLER. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT. THE CONTROLLER ((B)(4)) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE CONTROLLER FAILS VISUAL TESTING, HOWEVER THE PASSES ALL FUNCTIONAL TESTING. THE LOG FILES CONFIRM THE "ELECTRICAL FAULT" ALARMS, NONETHELESS THE CONTROLLER WAS WORKING WITHIN SPECIFICATIONS. THE ROOT CAUSE FOR THE REPORTED "ELECTRICAL FAULTS" WAS FOUND TO BE CONTAMINATION WITHIN THE PUMP DRIVELINE CONNECTOR, LIKELY DUE TO A COMBINATION OF DRIVELINE CONNECTOR HANDLING AND DRIVELINE/TUNNELING CAP DESIGN. THE MANUFACTURER HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. 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, INCLUDING TRANSPORTATION. THE INSTRUCTIONS FOR USE OUTLINES REQUIRED SURGICAL STEPS TO PREVENT DRIVELINE CONTAMINATION DURING TUNNELING. IT ADDITIONALLY WARNS THAT FAILURE TO FOLLOW INSTRUCTIONS ON PROTECTING THE DRIVELINE CONNECTOR OR IMPROPER USE OF THE DRIVELINE CAP COULD RESULT IN CONTAMINATION OR DAMAGE TO THE CONNECTOR AND ELECTRICAL FAULT ALARMS COULD OCCUR. IT FURTHER OUTLINES TO VERIFY THAT THE CONNECTOR IS DRY AND CLEAN BEFORE ATTACHING TO THE CONTROLLER. THE INSTRUCTIONS FOR USE AND PATIENT MANUAL ALSO INCLUDE A REFERENCE GUIDE FOR ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. HEARTWARE IS SUBMITTING THIS 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 (3007042319-2013-00676 AND 3007042319-2015-02695) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    APPROXIMATELY TWO AND A HALF WEEKS AFTER IMPLANT, THIS PATIENT DEVELOPED ELECTRICAL FAULT ALARMS. THESE WERE INTERMITTENT FOR OVER AN HOUR AND INCREASING IN FREQUENCY. THE PATIENT WAS ADMITTED TO HOSPITAL FOR OBSERVATION. 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
    387130 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1