BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 12987464 · Received December 13, 2021

    Report

    Report Number
    2916596-2021-07083
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 15, 2021
    Report Date
    February 23, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE SUBMITTED LOG FILES CONFIRMED DRIVELINE COMMUNICATION FAULT ALARMS. HOWEVER, A SPECIFIC CAUSE FOR THE DRIVELINE COMMUNICATION FAULT ALARM COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE ACCOUNT REPORTED THAT A DRIVELINE FAULT ALARM APPEARED WHEN CONNECTING THE PATIENT TO THE SYSTEM MONITOR. THE ALARM WAS CLEARED BUT RETURNED WITHIN FIVE SECONDS. THE CONTROLLER AND MODULAR CABLE WERE EXCHANGED, BUT THE ALARM RETURNED SHORTLY AFTERWARDS. ADDITIONALLY, THE ACCOUNT REPORTED THAT X-RAYS OF THE DRIVELINE REVEALED NO VISIBLE DAMAGE. THE SYSTEM CONTROLLER EVENT LOG FILE CONTAINS DATA FROM 20:49:37 ON (B)(6) 2021 TO 14:04:42 ON (B)(6) 2021. THE LOG FILE CONTAINS A PERSISTENT ALARM FOR DRIVELINE COMM FAULT DUE TO PERSISTENT COMM B FAULTS. THE DEVICE APPEARS TO BE OPERATING AS INTENDED AT THE SET SPEED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-002361. NO FURTHER EVENTS HAVE BEEN REPORTED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-002361 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), IS CURRENTLY AVAILABLE. SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING,¿ OUTLINES ALL SYSTEM CONTROLLER ALARMS, INCLUDING DRIVELINE COMMUNICATION FAULTS, AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THE HEARTMATE 3 LVAS PATIENT HANDBOOK, IS CURRENTLY AVAILABLE. SECTION 5 OF THE PATIENT HANDBOOK OUTLINES ALL SYSTEM CONTROLLER ALARMS, INCLUDING DRIVELINE COMMUNICATION FAULTS, AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. SECTION 8 ¿HANDLING EMERGENCIES LISTS EXAMPLES OF EMERGENCIES, INCLUDING DRIVELINE COMMUNICATION FAULTS, AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THESE EMERGENCIES. 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 COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE EMERGENCY ROOM FOR AN EVALUATION. WHEN THE PATIENT WAS CONNECTED TO THE SYSTEM MONITOR, A DRIVELINE FAULT ALARM APPEARED. THE ALARM WAS RESET, BUT RETURNED WITHIN 5 SECONDS. THE ALARM WAS ALSO ACTIVE ON THE SYSTEM CONTROLLER AND A YELLOW WRENCH "DRIVELINE FAULT ALARM" WAS ACTIVATED. THEIR MODULAR CABLE WAS INTACT AT THE TIME OF THE EVENT. TECHNICAL SERVICES PERFORMED A REVIEW OF THE LOG FILES AND CONFIRMED THERE WERE DRIVELINE COMMUNICATION FAULTS ON 15-NOV-2021 AT 8:49 PM THROUGH (B)(6) 2021 AT 2:04 PM. THEY SUGGESTED THE PATIENT'S MODULAR CABLE AND SYSTEM CONTROLLER BE EXCHANGED. PER THE RECOMMENDATION, THE MODULAR CABLE AND SYSTEM CONTROLLER WERE EXCHANGED, BUT THE DRIVELINE COMMUNICATION FAULT IMMEDIATELY RETURNED. TECHNICAL SERVICES FOUND ISSUES WITH THE COM B WIRE, WHICH APPEARED TO BE CAUSING THE FAULT AND THEY REQUESTED X-RAYS OF THE DRIVELINE, BUT IT APPEARED TO BE INTACT. THE CAUSE OF THE FAULTS WAS NOT CONFIRMED BY THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886988 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male