BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4143296 · Received October 6, 2014

    Report

    Report Number
    3007042319-2014-01037
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 26, 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

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE PATIENT KEPT EXPERIENCING ELECTRICAL FAULT ALARMS AFTER FIRST CLEANING ON (B)(4) 2014; REFERENCE IN A PREVIOUS COMPLAINT. A SECOND CLEANING PROCEDURE WAS PERFORMED TO REMOVE CONTAMINANTS. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT. PRELIMINARY LOG FILE ANALYSIS CONFIRMED THE REPORTED ALARMS; TWENTY-FIVE (25) ELECTRICAL FAULT ALARMS HAVE BEEN LOGGED SINCE (B)(4) 2014. THE CONTROLLER ((B)(4)) WAS RETUNED FOR EVALUATION. CONTROLLER FAILED VISUAL INSPECTION DUE TO CONTAMINATION ON DRIVELINE PORT PINS BUT PASSED FUNCTIONAL TESTING. 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. 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 (3007042319-2014-01037 AND 3007042319-2015-03075) 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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    APPROXIMATELY 3 DAYS FOLLOWING SERVICING FOR ELECTRICAL FAULT ALARMS RELATED TO CONTAMINATION, A SECOND CLEANING PROCEDURE WAS PERFORMED BY A HEARTWARE FIELD ENGINEER DUE TO ONGOING, INTERMITTENT ELECTRICAL FAULT ALARMS. THE CONTROLLER WAS EXCHANGED AND THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL ALARMS HAVE BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622470 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1