BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4100176 · Received September 18, 2014

    Report

    Report Number
    3007042319-2014-00978
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 23, 2014
    Report Date
    September 2, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 CONTROLLER WAS REPLACED AND RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING INSPECTION RECORDS DID NOT REVEAL MANUFACTURING CONTRIBUTED TO THE EVENT. THE BATTERY PASSED EXTERNAL VISUAL INSPECTION, AND FUNCTIONAL TEST. LOG FILE ANALYSIS REVEALED THE PUMP OPERATED IN THE NORMAL OPERATING RANGES DURING EVENT TIME. "NO SOUND" AS REPORTED IN THE EVENT DETAILS COULD NOT BE CONFIRMED, HOWEVER, ONE CONTROLLER POWER UP AND MOTOR START EVENT WAS LOGGED ON (B)(6) 2014 AT 19:23:58 INDICATING THAT BOTH POWER SOURCES WERE DISCONNECTED. ANALYSIS RESULTS FOUND THAT THE CONTROLLER PERFORMED AS EXPECTED. 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 REPORT MAY BE BASED ON INFORMATION WHICH HEARTWARE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. THE DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, HEARTWARE, OR ITS EMPLOYEES THAT THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, HEARTWARE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE HVAD REMAINS IMPLANTED IN THE PATIENT, THEREFORE IT WILL NOT BE RETURNED. HOWEVER, THE CONTROLLER ((B)(4)) HAS BEEN RECEIVED AND IS AWAITING FURTHER ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    APPROXIMATELY TWO MONTHS AND ONE WEEK POST HEARTWARE LVAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ELECTIVE CONTROLLER EXCHANGE AFTER HE REPORTED THAT NO ALARM OCCURRED WHEN HE HAD DISCONNECTED BOTH CONTROLLER POWER SOURCES. THE VAD COORDINATOR TESTED THE CONTROLLER AND FOUND ALARMS IN WORKING ORDER. HOWEVER, THEY DID DESCRIBE HEARING A "LOOSE COMPONENT" IN THE CONTROLLER. THERE WAS NO PATIENT INJURY. INVESTIGATION IS ONGOING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578007 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

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