BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5758389 · Received June 29, 2016

    Report

    Report Number
    3007042319-2016-02431
    Event Type
    Malfunction
    Date Received
    June 29, 2016
    Date of Event
    June 3, 2016
    Report Date
    June 3, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    UDI-DI
    00888707000376
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    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 AND PATIENT MANUAL OUTLINE THE STEPS FOR HANDLING AND PROPERLY CONNECTING POWER SOURCES, INCLUDING ENSURING PROPER ALIGNMENT, AS WELL AS INSTRUCTIONS NOT TO TWIST OR FORCE CONNECTIONS TOGETHER IN ORDER TO PREVENT DAMAGES. ADDITIONALLY, A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE AND THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIMES. IT ALSO PROVIDES INFORMATION ABOUT PROPER CARE OF THE SYSTEM AND WHAT TO DO IN CASE OF AN EMERGENCY. THERE ARE NO APPARENT CONTRIBUTING CLINICAL FACTORS TO THE REPORTED EVENT. ADDITIONAL SYSTEM COMPONENT BEING REPORTED FOR THIS EVENT: BATTERY: BAT317178 - EXPIRATION DATE: 03-31-20217. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BATTERY: (B)(4), CATALOG # 1650, MFR DATE: 03/02/2016, (B)(4), METHOD: VISUAL INSPECTION (B)(4), INTEROPERABILITY EVALUATION (B)(4), ACTUAL DEVICE EVALUATED (B)(4). RESULTS: NO FAILURE DETECTED (B)(4). CONCLUSION: NO FAILURE, DEVICE OPERATED WITHIN SPECIFICATION (B)(4). THE REPORTED EVENT OF POWER SWITCHING COULD NOT BE CONFIRMED ON THE RETURNED BATTERIES, (B)(4). VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. LOG FILE ANALYSIS WAS NOT CONDUCTED SINCE LOG FILES WERE NOT AVAILABLE. ANALYSIS OF THE DEVICES REVEALED THAT THE DEVICES MET SPECIFICATIONS; THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. NO FAILURE DETECTED, THE REPORTED POWER SWITCHING EVENT COULD NOT BE DUPLICATED AT THE BENCH LEVEL OR CONFIRMED THROUGH LOG FILE ANALYSIS AS LOGS WERE NOT AVAILABLE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BY MEDICAL PERSONNEL THAT A PATIENT EXPERIENCED TWO BATTERIES THAT "BEEP AND SWITCH TO OTHER SIDE". THERE WAS NO LOSS OF POWER, NO OTHER ALARMS. THE BATTERIES HAD A CHARGE GREATER THAN 25% WHEN THEY SWITCHED. IT IS NOTED THAT THE PATIENT DID NOT DROP BATTERIES, NOR WAS THERE ANY DAMAGE SEEN. THE CONTROLLER AS WELL WAS INSPECTED, NO DAMAGE SEEN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412290 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC 00888707000376

    Patients

    Seq Age Sex Outcome Treatment
    1