BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3925460 · Received July 10, 2014

    Report

    Report Number
    3007042319-2014-00702
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 13, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT, THEREFORE, IT WILL NOT BE RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT A PATIENT EXPERIENCED AN 'ELECTRICAL FAULT ALARM' ON MULTIPLE CONTROLLERS PROMPTING THE REQUEST FOR A MANUFACTURING REPRESENTATIVE. PATIENT SERVICING HISTORY REVEALED THERE WERE NO RELATED EVENTS PRIOR TO THE REPORTED EVENTS. THE DRIVELINE CONNECTOR WAS EVALUATED BY THE MANUFACTURING REPRESENTATIVE WHO CONFIRMED THE REPORTED 'FOREIGN MATERIAL' EVENT IN THE DRIVELINE CONNECTOR RESULTING IN THE CLEANING OF THE DRIVELINE CONNECTOR AND A CONTROLLER EXCHANGE. THE PATIENT BECAME SHORT OF BREATH AND AT ONE POINT STOPPED BREATHING DURING THE SERVICING PROCEDURE. PATIENT RETURNED TO BASELINE PARAMETERS SHORTLY AFTER RECONNECTING THE PUMP. THE CONTROLLERS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION REVEALED THE PRESENCE OF FOREIGN MATERIAL IN THE DRIVELINE CONNECTOR PORT FOR BOTH DEVICES; ADDITIONAL LOG FILE ANALYSIS CONFIRMED THE REPORTED 'ELECTRICAL FAULT' EVENTS FOR BOTH CONTROLLERS. 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 DURING IMPLANT, TUNNELING CAP DESIGN, AND THE DRIVELINE/CONNECTOR SEALING PROCESS. THE MANUFACTURER HAS AN OPEN 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. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS A BLANK, UNKNOWN AND AS NO INFORMATION (NI); THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. 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 THREE REPORTS (3007042319-2014-00702, 2015-02733 AND 3007042319-2015-02734) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    WHILE STILL IN THE HOSPITAL ONE WEEK POST IMPLANT, THE PATIENT EXPERIENCED MULTIPLE ELECTRICAL FAULT ALARMS NOT RESOLVED WITH CONTROLLER EXCHANGE. THE ALARMS WERE REPRODUCIBLE WITH MANIPULATION OF THE DRIVELINE. A HEARTWARE ENGINEER PERFORMED A CLEANING PROCEDURE AFTER INSPECTION REVEALED CONTAMINATION ON THE DRIVELINE CONNECTOR PINS. THE PATIENT WAS HEPARINIZED AND MONITORED IN THE ICU. WHILE THE PUMP WAS STOPPED FOR CLEANING, THE PATIENT BECAME SYMPTOMATIC WITH A "MOMENTARY" APNEIC EPISODE THAT QUICKLY STABILIZED WITH BAG VALVE MASK VENTILATION AND RESTARTING OF THE PUMP. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403244 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R CON093224_CONTROLLER