BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 15077646 · Received July 21, 2022

    Report

    Report Number
    2916596-2022-12396
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    July 18, 2022
    Report Date
    October 12, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    SECTION H6: INVESTIGATION FINDINGS: 4248 - USAGE PROBLEM IDENTIFIED. MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE LOG FILES PROVIDED BY THE ACCOUNT CONFIRMED A PUMP STOP WHICH APPEARED TO BE ASSOCIATED WITH THE DISCONNECTION OF THE DRIVELINE DURING THE FIRST REPORTED CONTROLLER EXCHANGE. A SPECIFIC CAUSE FOR THE CONTROLLER EXCHANGE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE CONTROLLER EVENT LOG FILE CONTAINED RELEVANT DATA FROM 18JUL2022, PER THE TIMESTAMPS. THE FIXED SPEED WAS SET TO 5400 REVOLUTIONS PER MINUTE (RPM); HOWEVER, THE MOTOR SPEED REMAINED AT 0.0 RPM THROUGHOUT THE RECORDED DATA. AT APPROXIMATELY 12:05, A DRIVELINE DISCONNECT ALARM WAS CAPTURED, FOLLOWED BY A CONTROLLER INTERNAL FAULT ALARM DUE TO FUSE B BEING OPEN. DESPITE ATTEMPTS TO SILENCE AND RESET THE CONTROLLER, THE ALARMS PERSISTED THROUGHOUT THE REMAINDER OF THE FILE. THE DRIVELINE DISCONNECT AND CONTROLLER FAULT ALARMS ARE CONSISTENT WITH THE PATIENT ATTEMPTING TO CONNECT TO THE CONTROLLER DURING THE FIRST REPORTED CONTROLLER EXCHANGE; HOWEVER, THE PUMP REMAINED STOPPED DUE TO THE DRIVELINE BEING INCORRECTLY INSERTED INTO THE CONTROLLER BY 180 DEGREES WHICH WAS CONFIRMED THROUGH THE EVALUATION OF THE RETURNED CONTROLLER, HSC-030322 (RELATED MANUFACTURER REPORT NUMBER 2916596-2022-12397). THE PATIENT REMAINED ONGOING ON HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) , UNTIL (B)(6) 2022 WHEN THE PATIENT ULTIMATELY EXPIRED. NO PRODUCT WAS RETURNED FOR EVALUATION (RELATED MANUFACTURER REPORT NUMBER 2916596-2022-12994). THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 2 OF THE IFU, 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." ADDITIONALLY, SECTION 2 OF THE IFU, UNDER "CONNECTING THE DRIVELINE TO THE SYSTEM CONTROLLER", 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 2 OF THE PATIENT HANDBOOK ALSO ADVISES THE USER TO ¿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. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, PROMPTLY RECONNECT IT TO RESUME PUMP OPERATION¿. THE PATIENT HANDBOOK ALSO EXPLAINS THAT THE PUMP CANNOT RUN WITHOUT POWER. SECTION 7 OF THE IFU AND SECTION 5 OF THE PATIENT HANDBOOK ADDRESS ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. FURTHERMORE, SECTION 8 OF THE PATIENT HANDBOOK PROVIDES EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS.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 SYSTEM CONTROLLER (HSC-030986) WAS EXCHANGED FOR SYSTEM CONTROLLER (HSC-030322) FOR AN UNKNOWN REASON. WHILE HSC-030322 WAS IN USE, CONTROLLER INTERNAL FAULT, PUMP OFF, DRIVELINE DISCONNECTED, AND LOW FLOW ALARMS WERE ACTIVE. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO LOSS OF CONSCIOUSNESS WHEN THE PUMP STOP ALARM WAS ACTIVE. HSC-030322 WAS EXCHANGED FOR HSC-017539 DUE TO THE ACTIVE ALARMS AND THE ALARMS RESOLVED. AS OF (B)(6) 2022, THE PATIENT WAS INTUBATED AND WAS UNDER EXAMINATION. MFR # FOR HSC-030322: 2916596-2022-12397, MFR# FOR HSC-030986: 2916596-2022-12398.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719467 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 6556196

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Unknown Hospitalization| R