BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5171696 · Received October 23, 2015

    Report

    Report Number
    3007042319-2015-02567
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    April 26, 2014
    Report Date
    April 28, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE "ELECTRICAL FAULT" ALARMS. THE SITE DECIDED TO THE REPLACE THE CONTROLLER OF THEIR OWN VOLITION, HOWEVER THE ALARMS REMAINED. PRELIMINARY LOG FILE ANALYSIS CONFIRMED THE REPORTED ALARMS MAY BE A SIGN OF CONTAMINATION. UPON EVALUATION BY THE MANUFACTURER'S REPRESENTATIVE, FOREIGN MATERIAL WAS FOUND WITHIN THE DRIVELINE CONNECTOR AND A CLEANING PROCEDURE WAS PERFORMED TO REMOVE CONTAMINANTS. THERE WERE NO REPORTED INJURIES AS A RESULT OF THESE EVENTS. THE REPORTED CONTROLLER ((B)(4)) WAS RETURNED TO THE MANUFACTURER AND TESTED FOR FUNCTIONALITY. THE CONTROLLER ((B)(4)) PASSED FUNCTIONAL TESTING AND THE ALARMS COULD NOT BE REPRODUCED, HOWEVER CONTAMINATION WAS FOUND IN THE CONTROLLER'S CONNECTOR PORTS. THE ROOT CAUSE FOR THE REPORTED "ELECTRICAL FAULTS" AND "FOREIGN MATERIAL" 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/OR THE DRIVELINE/CONNECTOR SEALING DESIGN. 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. 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 THREE OF THREE REPORTS (3007042319-2015-02565, 2015-02566 AND 3007042319-2015-02567) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT THE PATIENT HAD MULTIPLE "ELECTRICAL FAULT" ALARMS. THE SITE DECIDED TO PERFORM A CONTROLLER EXCHANGE, HOWEVER THE ALARMS CONTINUED AFTER THE EXCHANGE. PRELIMINARY LOG FILE ANALYSIS REVEALED THAT THE REASON FOR THE ALARMS MAY BE DUE TO CONTAMINATION IN THE DRIVELINE CONNECTOR. A MANUFACTURER'S REPRESENTATIVE ASSESSED THE DEVICE AND PERFORMED A CLEANING PROCEDURE PER THE MANUFACTURER SPECIFICATION TO REMOVE CONTAMINANTS. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO REPORTED INJURIES AS A RESULT OF THIS EVENT. BOTH CONTROLLERS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700899 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1