BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 14026603 · Received April 6, 2022

    Report

    Report Number
    2915596-2022-00001
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    May 9, 2021
    Report Date
    May 23, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE EVALUATION OF THE SUBMITTED LOG FILES CONFIRMED DRIVELINE DISCONNECTS AND ENSUING SYSTEM STOPPAGES. THE CONTROLLER EVENT LOG FILE CAPTURED SEVERAL CONNECTIONS AND DISCONNECTIONS OF THE DRIVELINE, RESULTING IN SYSTEM STOPPAGES THROUGHOUT THE DURATION OF THE CAPTURED DATA. COM A, COM B, LOW PUMP CURRENT, POWER B BROKEN, LOW FLOW, PUMP OFF, AND LOW SPEED FAULTS WERE CAPTURED DURING THESE EVENTS. NO OTHER ATYPICAL EVENTS WERE CAPTURED. DESPITE THESE ALARMS, THE PUMP APPEARED TO FUNCTION AS INTENDED. THE LVAD EVENT LOG FILE CAPTURED SOFTWARE RESET, ROTOR DISPLACEMENT, LVAD OPC, AND NOT INITIALIZED FAULTS ON (B)(6) 2022 AT 09:46:12, CONSISTENT WITH THE DRIVELINE DISCONNECT. THE CONTROLLER AND LVAD PERIODIC LOG FILES DID NOT CAPTURE ANY ATYPICAL EVENTS. IT WAS REPORTED THAT A MODULAR CABLE EXCHANGE WAS PERFORMED, BUT THE ACCOUNT DID NOT PROVIDE A REASON FOR THE MULTIPLE DRIVELINE DISCONNECTS AND PUMP STOPPAGES. THERE WERE NO PATIENT CONDITIONS. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-020464. NO PRODUCT IS AVAILABLE FOR INVESTIGATION. THE HEARTMATE 3 LVAS IFU, REV. C, IS CURRENTLY AVAILABLE. SECTION 2 "SYSTEM OPERATIONS" (UNDER "SYSTEM CONTROLLER WARNINGS AND CAUTIONS") STATES, "CHECK THE SYSTEM CONTROLLER DRIVELINE CONNECTOR TO CONFIRM THAT THE DRIVELINE IS SECURELY INSERTED IN THE SOCKET. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, THE PUMP STOPS. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, PROMPTLY RECONNECT IT TO RESUME PUMP OPERATION." SECTION 2 ALSO CONTAINS A SECTION TITLED "CONNECTING THE DRIVELINE TO THE SYSTEM CONTROLLER", WHICH PROVIDES INSTRUCTIONS ON CONNECTING/DISCONNECTING THE DRIVELINE TO/FROM THE SYSTEM CONTROLLER AND MAKING SURE THAT IT IS FULLY AND PROPERLY INSERTED INTO THE SYSTEM CONTROLLER SOCKET. SECTION 7 "ALARMS AND TROUBLESHOOTING" OUTLINES ALL SYSTEM CONTROLLER ALARMS, INCLUDING DRIVELINE DISCONNECTED ALARMS, AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D, IS ALSO CURRENTLY AVAILABLE. THIS HANDBOOK WARNS IN SEVERAL SECTIONS: "CHECK THE SYSTEM CONTROLLER DRIVELINE CONNECTOR OFTEN TO CONFIRM THAT THE DRIVELINE IS SECURELY INSERTED IN THE SOCKET. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, THE PUMP WILL STOP." AND "THE PUMP WILL STOP IF THE DRIVELINE IS DISCONNECTED FROM THE SYSTEM CONTROLLER. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, RECONNECT IT RIGHT AWAY TO RESTART THE PUMP. THE PUMP CANNOT RUN WITHOUT POWER." SECTION 3 "POWERING THE SYSTEM" OUTLINES THE PROPER METHOD FOR CHANGING FROM THE POWER MODULE OR MOBILE POWER UNIT TO BATTERIES AND VICE-VERSA UNDER THE SUB-SECTION TITLED ¿SWITCHING POWER SOURCES¿. IN ADDITION, THE PATIENT HANDBOOK STATES, "CALL YOUR HOSPITAL CONTACT IF YOU THINK THAT, FOR ANY REASON, ANY PORTION OF YOUR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR YOU ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT." THE PATIENT HANDBOOK ALSO CONTAINS A SECTION ON HANDLING EMERGENCIES. SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ CONTAINS INFORMATION REGARDING ALL SYSTEM CONTROLLER ALARMS, INCLUDING THE DRIVELINE DISCONNECTED HAZARD ALARM, AND THE PROPER ACTIONS ASSOCIATED WITH THEM. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-020464 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE PUMP SHIPPED ON (B)(6) 2020. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A FEW LEFT VENTRICULAR ASSIST DEVICE (LVAD) PUMP DISCONNECT EVENTS. THE STARTUP EVENTS SHOWED NO PUMP BEING CONNECTED AS WELL AS SHUTDOWN SEQUENCES AT VARIOUS DATES DURING ITS HISTORY. A REVIEW OF THE LOG FILES REVEALED FEW CONNECTIONS AND DISCONNECTIONS TO AN LVAD PUMP, STARTUP EVENTS THAT SHOWED NO PUMP CONNECTED, AND SHUTDOWN SEQUENCES, ALL AT VARIOUS DATES DURING THIS HISTORY. THE PATIENT HAD A CONTROLLER CONNECTED EVENT ON (B)(6) 2022 AT 0947.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 2916596-2022-10158.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042922 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7394671 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male