BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 7691399 · Received July 16, 2018

    Report

    Report Number
    3007042319-2018-03045
    Event Type
    Malfunction
    Date Received
    July 16, 2018
    Date of Event
    June 16, 2018
    Report Date
    October 5, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: FIVE BATTERIES ((B)(4)) AND CONTROLLER ((B)(4)) WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS WAS NOT CONDUCTED SINCE LOG FILES WERE NOT AVAILABLE. AS A RESULT, THE REPORTED EVENT COULD NOT BE CONFIRMED. A POWER SOURCE LUBRICATION PROCEDURE WAS PERFORMED ON JUNE 20, 2018 TO MITIGATE THE REPORTED CONDITIONS AND THE POWER SOURCES REMAIN IN USE. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; A POSSIBLE ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENTS CAN BE ATTRIBUTED TO COMMUNICATION ERRORS AND/OR MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND POWER SOURCES. ADDITIONAL PRODUCTS: BATTERY / (B)(4). BATTERY / (B)(4). BATTERY / (B)(4). BATTERY / (B)(4). BATTERY / (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    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: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2016-10-31. UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION?: NO. MFG DATE: 2015-10-31. LABELED FOR SINGLE USE?: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2016-10-31. UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION?: NO. MFG DATE: 2015-10-31. LABELED FOR SINGLE USE?: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2016-10-31. UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION?: NO. MFG DATE: 2015-10-31. LABELED FOR SINGLE USE?: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2016-10-31. UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION?: NO. MFG DATE: 2015-10-31. LABELED FOR SINGLE USE?: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY: BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2016-10-31. UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION?: NO. MFG DATE: 2015-10-31. LABELED FOR SINGLE USE?: NO. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS POWER SWITCHING WITH THE CONTROLLER AND FIVE BATTERIES. SERVICING WAS PERFORMED, AND THE CONTROLLER AND BATTERIES REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534460 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420

    Patients

    Seq Age Sex Outcome Treatment
    1 MCS VAD