BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4180881 · Received October 17, 2014

    Report

    Report Number
    3007042319-2014-01078
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 25, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IMPLANTED IN THE PATIENT, THEREFORE IT WILL NOT BE RETURNED. DEVICE EVALUATED IN THE FIELD BY HEARTWARE CLINICAL ENGINEERING PERSONNEL. THE CONTROLLER HAS BEEN RECEIVED AND THE EVALUATION IS STILL ONGOING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. THE "ELECTRICAL FAULT' FIELD FAILURE WAS UNABLE TO REPLICATE. THE ROOT CAUSE WAS UNDETERMINED, BUT LIKELY RELATED TO THE CONTAMINATION IN THE VAD CONNECTOR. THIS CONFIRMS WHAT THE CLINIC FOUND IN THE FIELD. FOREIGN MATERIAL WAS FOUND IN THE PUMP CONNECTOR CONTACTS EVEN AFTER THE CLINICAL CLEANING. THE CONTROLLER CONNECTED TO STANDARD RELEASED COMPONENTS AND PASSED THE FUNCTIONAL TEST. IN ADDITION, THE CONTROLLER PASSED BENCH TESTING ALSO. A TWO-FINGERS TUG AND PULL TEST, CONNECTED TO TWO DIFFERENT CLOSED LOOP BATH FIXTURES, INTERNAL/EXTERNAL VISUAL INSPECTION, AND THE ENVIRONMENT STRESS SCREENING WITH THE TEMPERATURE CYCLED BETWEEN -40C AND +80C FOR 14 CYCLES. ALARM OR UNEXPECTED INTERRUPTION EVENT WAS NOT OBSERVED. THERE WERE NO FURTHER ANOMALIES FOUND, THEREFORE NO FURTHER INVESTIGATION REQUIRED. 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 (IFU) NOTE SPECIFICALLY STATES TO PROTECT 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. WHILE THERE IS NO AVAILABLE INFORMATION AT THIS TIME TO INDICATE THE CAUSE OF THIS REPORTED EVENT, IT MAY BE POSSIBLE THAT FOREIGN MATERIAL WAS INTRODUCED INTO THE DRIVELINE CONNECTOR DURING THE IMPLANT PROCEDURE. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER (B)(4) DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HEARTWARE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. 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 (3007042319-2014-01078 AND 3007042319-2015-10001) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. CONTROLLER RECEIVED 03/29/2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 1 MONTH AFTER IMPLANTATION SEVERAL ELECTRICAL FAULT ALARMS OCCURRED. IT WAS ALSO REPORTED THAT VISIBLE CONTAMINATION INSIDE THE CONNECTOR AND CONTROLLER WAS NOTED. A CLEANING PROCEDURE WAS PERFORMED IN THE FIELD BY THE CLINICAL ENGINEER AND THE CONTROLLER WAS EXCHANGED. THE PATIENT TOLERATED THE PROCEDURE WITHOUT INJURY. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662557 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROLLER - (B)(4)