BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19165642 · Received April 23, 2024

    Report

    Report Number
    2916596-2024-02511
    Event Type
    Death
    Date Received
    April 23, 2024
    Date of Event
    March 21, 2024
    Report Date
    September 12, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED LOW FLOW ALARMS, AS WELL AS A PUMP STOP DUE TO A DRIVELINE DISCONNECT EVENT. ACCORDING TO THE ACCOUNT, THE DRIVELINE WAS DISCONNECTED DUE TO USER ERROR. HOWEVER, A SPECIFIC CAUSE FOR THE LOW FLOW ALARMS COULD NOT BE CONCLUSIVELY DETERMINED. FURTHERMORE, A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS AND PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE SUBMITTED CONTROLLER EVENT LOG FILE CAPTURED A PUMP STOP EVENT ON (B)(6) 2024 DUE TO THE DRIVELINE BEING DISCONNECTED. THIS EVENT WAS ASSOCIATED WITH LOW FLOW HAZARD, LVAD OFF, AND DRIVELINE DISCONNECT ALARMS. NO EXTERNAL POWER ALARMS WERE ALSO ACTIVE DURING THIS TIME DUE TO A DOUBLE POWER CABLE DISCONNECT. DURING THE PUMP STOP EVENT, THE LOW-SPEED LIMIT APPEARED TO BRIEFLY RESET TO THE DEFAULT SPEED OF 5000 REVOLUTIONS PER MINUTE (RPM). AFTER THE DRIVELINE WAS RECONNECTED, THE LOW-SPEED LIMIT RETURNED TO ITS SET VALUE OF 4300 RPM, HOWEVER THE PUMP REMAINED OFF SINCE IT WAS STILL NOT CONNECTED TO AN EXTERNAL POWER SOURCE. INTENTIONAL PUMP STOP FAULT FLAGS BECAME ACTIVE AT THIS TIME TO PREVENT THE PUMP FROM RESTARTING ON THE BACKUP BATTERY, PER DESIGN. NO EXTERNAL POWER ALARMS RESOLVED ONCE THE POWER CABLES WERE RECONNECTED TO THE POWER MODULE, AND THE PUMP RAMPED UP TO THE STORED PATIENT SPEED WITHOUT ISSUE. OUTSIDE OF THE PUMP STOP EVENT, SEVERAL TRANSIENT LOW FLOW HAZARD ALARMS WERE CAPTURED. OF NOTE, PULSATILITY INDEX (PI) VALUES WERE ELEVATED DURING THE LOW FLOW EVENTS. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED, AND THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE STORED PATIENT SPEED WHILE THE DRIVELINE WAS CONNECTED. 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 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING INFECTION AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. THIS SECTION ALSO PROVIDES AN EXPLANATION OF PUMP PARAMETERS, INCLUDING FLOW. THE IFU EXPLAINS THAT PUMP FLOW IS A CALCULATED VALUE THAT IS ESTIMATED BASED ON PUMP POWER. SECTION 2 OF THE IFU, "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." 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, ¿HOW YOUR HEART PUMP WORKS¿, 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 3 OF THE IFU, ¿POWERING THE SYSTEM¿, AND SECTION 3 OF THE PATIENT HANDBOOK, ¿POWERING THE SYSTEM¿, ADDRESS HOW TO PROPERLY SWITCH BETWEEN POWER SOURCES. SECTION 4 OF THE IFU, ¿SYSTEM MONITOR¿, PROVIDES INFORMATION ABOUT THE PUMP FLOW DISPLAY AND THE LOW FLOW HAZARD ALARM CONDITION. THIS SECTION STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN THE ESTIMATED PUMP FLOW IS LESS THAN 2.5 LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. THIS SECTION ALSO NOTES THAT, IN GENERAL, THE MAGNITUDE OF THE PULSATILITY INDEX (PI) VALUE IS RELATED TO THE AMOUNT OF ASSISTANCE PROVIDED BY THE PUMP. HIGHER VALUES INDICATE MORE VENTRICULAR FILLING AND HIGHER PULSATILITY (I.E., THE PUMP IS PROVIDING LESS SUPPORT TO THE LEFT VENTRICLE). SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS INFECTION AS A POTENTIAL LATE POST-IMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. SEVERAL SECTIONS OF THE IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING INFECTION PREVENTION, AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. FURTHERMORE, SECTION 5 OF THE PATIENT HANDBOOK, "ALARMS AND TROUBLESHOOTING", AND SECTION 7 OF THE IFU, "ALARMS AND TROUBLESHOOTING", ADDRESS SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. THESE DOCUMENTS ALSO WARN OF EVENTS THAT MAY CAUSE THE PUMP TO STOP AND HOW TO PREVENT PUMP STOPS FROM OCCURRING. SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES,¿ ALSO PROVIDES EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS. THE PATIENT HANDBOOK ALSO INSTRUCTS USERS 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. FOR PATIENTS WITH LOW FLOW SOFTWARE SYSTEM CONTROLLERS, THE HEARTMATE 3 LVAS POCKET GUIDES TO ALARMS FOR PATIENTS AND CLINICIANS EXPLAIN THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN THE ESTIMATED PUMP FLOW IS LESS THAN 2.0 LPM. 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS HOSPITALIZED IN A NURSING HOSPITAL AND WAS SCHEDULED TO BE ADMITTED TO THE MAIN HOSPITAL TO MANAGE HIDDEN INFECTIONS DUE TO AN INCREASE IN C-REACTIVE PROTEIN (CRP) BY 8 POINTS AT THE NURSING HOSPITAL. HOWEVER, THE PATIENT PASSED AWAY DUE TO A SUDDEN CARDIAC ARREST/CARDIOGENIC SHOCK AT ANOTHER HOSPITAL DESPITE CARDIOPULMONARY RESUSCITATION ATTEMPTS. THE DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED AND THE DEVICE REPORTEDLY OPERATED AS EXPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO A NURSING HOSPITAL AND THE WARD NURSE HAD DISCONNECTED THE DRIVELINE DUE TO A LOW FLOW ALARM WHICH COULD NOT BE FIGURED OUT. THE NURSE THOUGHT THAT WOULD RESOLVE THE ISSUE. THE DRIVELINE WAS DISCONNECTED FOR A FEW MINUTES AND AFTER IT WAS REATTACHED THE LOW FLOW LIMIT WAS SET TO 5000RPM INSTEAD OF THE INITIAL 4400 RPM. THE IMPLANTING CENTER WANTED TO KNOW THE REASON FOR THE CHANGED LOW FLOW LIMIT. THE LOG FILES CAPTURED LOW FLOW EVENTS ON (B)(6) 2024 THAT APPEARED TO BE RELATED TO THE PATIENT'S HEMODYNAMICS. A PUMP STOP WAS ALSO NOTED THAT WAS CAUSED BY A COMBINATION OF THE DRIVELINE BEING DISCONNECTED AND AN INTENTIONAL PUMP STOP THAT WAS ACTIVATED BY PRESSING THE PUMP STOP BUTTON ON THE SYSTEM MONITOR. THE LOW SPEED LIMIT DEFAULTED TO 5000RPM BECAUSE THE COMMUNICATION WITH THE PUMP WAS LOST WHEN THE DRIVELINE WAS DISCONNECTED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT DUE TO THE DRIVELINE BEING DISCONNECTED. HOWEVER, THE PATIENT PASSED AWAY ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272988 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 9151615 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Death