BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 7126979 · Received December 18, 2017

    Report

    Report Number
    3007042319-2017-05138
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    November 3, 2017
    Report Date
    May 16, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000420
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS: PRODUCT EVENT SUMMARY: THE CONTROLLER (B)(4) AND SIX BATTERIES (B)(4) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER AND BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. AN ATTEMPT WAS MADE TO REPLICATE THE ISSUE BY MANIPULATING THE BATTERIES' CONNECTION TO THE CONTROLLER DURING THE ANALYSIS OF THE UNITS. RESULTS REVEALED THAT THE ELECTRICAL CONNECTIONS BETWEEN THE BATTERIES AND THE CONTROLLER WERE STABLE. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A SOFTWARE WITH A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF DATA FILES REVEALED POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4). AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION IS OPEN FOR MOMENTARY DISCONNECTIONS. ADDITIONAL PRODUCTS: BATTERY (B)(4). (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 AND DESTINATION THERAPY 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. OTHER DEVICES INVOLVED IN THIS EVENT: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY BATTERY /(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-07-31 UDI (B)(4), RETURN DATE: (B)(6) 2017, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-07-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY /(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-07-31 UDI #: (B)(4), RETURN DATE: (B)(6) 2017, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-07-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY /(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-07-31 UDI #: (B)(4), RETURN DATE: (B)(6) 2017, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-07-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY /(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-07-31 UDI #: (B)(4), RETURN DATE: (B)(6) 2017, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-07-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY /(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-07-31 UDI #: (B)(4), RETURN DATE: (B)(6) 2017: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-07-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY /(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-07-31 UDI #: (B)(4), RETURN DATE: (B)(6) 2017, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-07-31(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONTROLLER AND BATTERIES EXHIBITED POWER SWITCHING FROM ONE PORT OF THE CONTROLLER TO THE OTHER, DESPITE THE BATTERY CAPACITIES BEING GREATER THAN TWENTY-FIVE PERCENT (25%). THE CONTROLLER AND BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904449 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420-MCS 00888707000420

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR 1104 VAD