BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4894720 · Received July 7, 2015

    Report

    Report Number
    3007042319-2015-01379
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    June 13, 2015
    Report Date
    June 22, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRIVELINE CABLE WAS NOT RETURNED AS IT REMAINS IMPLANTED. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DRIVELINE CABLE ((B)(4)) MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE TWO CONTROLLERS' LOG FILES, WHICH REVEALED ELECTRICAL FAULT ALARMS ON THE REPORTED EVENT DATE. THE MOST LIKELY ROOT CAUSE OF THE ELECTRICAL FAULT ALARMS IS CONTAMINATION BY FOREIGN MATERIAL, AS OBSERVED IN THE FIELD AND FOUND DURING TESTING. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO ADDRESS THIS ISSUE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF TWO REPORTS (3007042319-2015-01379 AND 3007042319-2015-01380) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. 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. THE INSTRUCTIONS FOR USE (IFU) 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. THE IFU AND PATIENT MANUAL ALSO INCLUDE A REFERENCE GUIDE FOR ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF TWO REPORTS (3007042319-2015-01379 AND 3007042319-2015-01380) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. PUMP REMAINS IMPLANTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM ENGLAND THAT WHILE IN THE HOSPITAL THE PATIENT WAS EXPERIENCING ELECTRICAL FAULTS WHICH STARTED ON (B)(6) 2015, 10 DAYS POST VENTRICULAR ASSIST DEVICE (VAD) IMPLANTATION. ON (B)(6) 2015, THE PATIENT EXPERIENCED A VERY SHORT SELF-RESOLVING PUMP STOP. THE HOSPITAL STAFF TRIED TO PERFORM A CLEANING OF THE CONNECTOR BY THEMSELVES WITHOUT INFORMING THE MANUFACTURER. THE ORIGINAL CONTROLLER WAS EXCHANGED WITH A BACK-UP CONTROLLER. THE ELECTRICAL FAULTS STARTED TO OCCUR AGAIN ON (B)(6) 2015 AND THE HOSPITAL INFORMED THE MANUFACTURER'S FIELD SAFETY ENGINEER ON (B)(6) 2015. THE FIELD SAFETY ENGINEER ARRIVED AT THE SITE ON (B)(6) 2015 AT THE SITE AND. EXTERNAL VISUAL INSPECTION SHOWED A CLOUDY WIRE (BLACK WIRE). THE CONNECTOR WAS HARD TO MOVE IN THE AXIAL POSITION. "IT FELT STICKY." A DRIVELINE CONNECTOR CLEANING WAS THEN PERFORMED ON (B)(6) 2015 BY THE FIELD SAFETY ENGINEER PER THE MANUFACTURER'S PROCEDURE TO REMOVE THE CONTAMINATION FROM THE INSIDE OF THE CONNECTOR. THE CLEANING PROCEDURE WAS PERFORMED IN THE OPERATING ROOM AND THE PATIENT WAS PREPPED WITH 10,000 UNITS OF HEPARIN. THE SERVICE EVALUATION FOUND THE FOLLOWING: THERE WERE ELECTRICAL FAULTS WITH ONE SELF-RESOLVING PUMP STOP. THE INSPECTION SHOWED VISIBLE CONTAMINATION WITHIN THE DRIVELINE CONNECTOR AS WELL AS THE CONTROLLER SOCKET. A STICKY GREENISH/BROWN SUBSTANCE WAS VISIBLE. THREE CLEANING CYCLES WERE NECESSARY, EACH LASTING 60 SECONDS OF PUMP-OFF TIME. THE PATIENT TOLERATED THE PUMP-OFF TIME "VERY WELL" AND THERE WERE NO UNANTICIPATED OBSERVATIONS. THE CONTROLLER WAS REMOVED FROM SERVICE DUE TO CONTAMINATION IN THE CONNECTOR SOCKET. IT WAS INDICATED THAT THE REPAIR ACTION SOLVED THE PROBLEM AND THERE WAS NO EFFECT ON THE PATIENT. THIS IS 1 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438357 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R