BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 20387892 · Received October 7, 2024

    Report

    Report Number
    2916596-2024-06380
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 8, 2024
    Report Date
    December 17, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED LVAD SOFTWARE FAULTS. ALTHOUGH A SPECIFIC CAUSE FOR THE LVAD SOFTWARE FAULTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, THE EVENTS DID NOT APPEAR TO HAVE AN EFFECT ON PUMP OPERATION. THE SUBMITTED CONTROLLER EVENT LOG FILES COLLECTIVELY CONTAINED DATA FROM 09:38:37 THROUGH 09:42:15, AND FROM 11:42:20 THROUGH 11:47:57 ON 18SEP2024. INTERMITTENT F63 LVAD FAULTS WERE CAPTURED IN THE SOFTWARE FAULT COLUMN FROM THE BEGINNING OF THE CAPTURED DATA THROUGH 11:46:01. THE DRIVELINE WAS THEN DISCONNECTED AT 11:46:02 AND RECONNECTED AT 11:46:09, WHICH APPEARS CONSISTENT WITH THE RECOMMENDED DRIVELINE DISCONNECT/RECONNECT IN ORDER TO CYCLE POWER. THE LVAD SOFTWARE FAULTS WERE RESOLVED BY THE POWER CYCLE, AND THE PUMP RAMPED BACK UP TO THE SET SPEED WITHOUT ISSUE ONCE THE DRIVELINE WAS RECONNECTED. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED, AND THE DEVICE APPEARED TO OPERATE AS INTENDED AT THE SET SPEED WHEN THE DRIVELINE WAS CONNECTED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER MLP-033477. NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE (IFU) REV. C AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK REV. D ARE CURRENTLY AVAILABLE. SECTION 7 OF THE IFU AND SECTION 5 OF THE PATIENT HANDBOOK OUTLINE SYSTEM ALARMS, AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THESE EVENTS. FURTHERMORE, THE PATIENT HANDBOOK INSTRUCTS THE USER TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS IN CLINIC AND HAD THEIR LOG FILES DOWNLOADED. THE LOG FILES SHOWED NO OR LIMITED EVENTS WHEN THE SYSTEM CONTROLLER WAS DISCONNECTED AND RESET. THE LOG FILES WERE REVIEWED AND A LEFT VENTRICULAR ASSIST DEVICE (LVAD) SOFTWARE FAULT ALARM (CODE 63), A COMMUNICATION ERROR, WAS SEEN. IT WAS RECOMMENDED IF THE PATIENT CAN TOLERATE IT TO CYCLE THE PUMP POWER BY DISCONNECTING AND RECONNECTING THE DRIVELINE. THE RESET WAS DONE AND THE MODULAR CABLE CONNECTIONS WERE INSPECTED. THERE WAS NO CORROSION SEEN IN THE CONNECTION. THE LOG FILES WERE REVIEWED AGAIN AND CAPTURED THE DRIVELINE DISCONNECT AND THE PUMP RESTART PROCESS. THE LVAD SOFTWARE FAULT WAS RESOLVED. THE PATIENT WAS STABLE AFTER THE PUMP RESET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2547513 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8547428 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male