BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER, US, EP

    MDR report key: 12788897 · Received November 10, 2021

    Report

    Report Number
    2916596-2021-06204
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    October 12, 2021
    Report Date
    January 7, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010630
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF MULTIPLE POWER CABLE DISCONNECT AND LOW VOLTAGE ALARMS AND DAMAGED POWER CABLES CAN BE CONFIRMED BASED ON THE PROVIDED PHOTOS AND THE DATA CONTAINED IN THE PROVIDED LOG FILE. A LOG FILE PROVIDED BY THE CUSTOMER WAS REVIEWED. THE LOG FILE CONTAINED EVENTS RECORDED FROM THE TIME STAMP OF DAY 1115, 19 HOURS AND 42 MINUTES TO DAY 1115, 21 HOURS AND 28 MINUTES WHERE MULTIPLE POWER CABLE DISCONNECT AND LOW VOLTAGE ADVISORY ALARMS WERE RECORDED. THE PUMP OPERATION WAS NOT AFFECTED AND THE SYSTEM MAINTAINED THE DESIRED SET SPEED WITH NO INTERRUPTIONS. THE REVIEW OF THE PROVIDED PHOTOS CONFIRMED THAT BOTH STRAIN RELIEFS (BLACK AND WHITE) WERE DAMAGED/SEPARATED AT THE POWER CONNECTORS. THE SYSTEM CONTROLLER SERIAL NUMBER (B)(6) WAS NOT AVAILABLE FOR EVALUATION. PER THE ADDITIONAL INFORMATION THE CONTROLLER AND THE CLIPS WERE EXCHANGED AND THERE WERE NO FURTHER EVENTS REPORTED. THE CONTROLLER WILL NOT BE RETURNED FOR EVALUATION. PATIENT HANDBOOK AND OPERATING MANUAL COVERS ALL ALARMS (VISUAL AND AUDIBLE) ON THE SYSTEM CONTROLLER AND WHAT ACTION SHOULD BE PERFORMED WHEN THEY DO OCCUR. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE CONTROLLER WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LOG FILES WERE SENT FOR ANALYSIS DUE TO MULTIPLE POWER CABLE DISCONNECTS AND LOW VOLTAGE ADVISORIES. BOTH THE BLACK AND WHITE POWER LEADS ON THE CONTROLLER APPEARED DAMAGED. LOG FILE REVIEW CONFIRMED ODD STRINGS OF POWER CABLE DISCONNECTS AND LOW VOLTAGE ADVISORIES. THESE ALARMS WERE OCCURRING ON BOTH WHITE AND BLACK POWER LEADS. THERE WERE NO OTHER UNUSUAL EVENTS SEEN WITHIN THE LOG FILE AND THE VENTRICULAR ASSIST DEVICE (VAD) WAS FUNCTIONING AS INTENDED. THE PATIENT'S CONTROLLER AND CLIPS WERE REPLACED AND ALARMS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684653 HEARTMATE II SYSTEM CONTROLLER, US, EP VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 103696 6021638 00813024010630

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male