BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 17436453 · Received August 1, 2023

    Report

    Report Number
    2916596-2023-05342
    Event Type
    Death
    Date Received
    August 1, 2023
    Date of Event
    July 13, 2023
    Report Date
    November 1, 2023
    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
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS AND SUBSEQUENT PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. REVIEW OF THE SUBMITTED LOG FILES CONFIRMED LOW FLOW ALARMS; HOWEVER, A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, EVALUATION OF THE SUBMITTED LOG FILES CONFIRMED A PUMP STOP DUE TO THE MOTOR STOP COMMAND BEING RECEIVED. ACCORDING TO THE ACCOUNT THE PUMP WAS INTENTIONALLY STOPPED AND RESTARTED. THE CONTROLLER EVENT LOG FILE CONTAINED EVENTS FROM 13JUL2023. LOW FLOW HAZARD ALARMS WERE CAPTURED THROUGHOUT THE FILE WITH ESTIMATED FLOW ULTIMATELY DECREASING TO VALUES HOVERING AT OR SLIGHTLY ABOVE 0 LITERS PER MINUTE (LPM). DURING THE LOW FLOW STATE, SEVERAL MANIPULATIONS OF THE FIXED SPEED WERE MADE. ADDITIONALLY, A BRIEF PUMP STOP WAS CAPTURED DUE TO THE MOTOR STOPPED COMMAND BEING RECEIVED. FOLLOWING THIS EVENT, THE PUMP REGAINED OPERATION AT THE FIXED SPEED; HOWEVER, FLOW DID NOT RECOVER. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED. DESPITE THE OBSERVED EVENTS, THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE SET SPEED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THIS EVENT; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. HM3 LVAS, SERIAL NUMBER (B)(6), WAS NOT RETURNED FOR EVALUATION. IF THE PUMP IS RETURNED AT A LATER DATE, THIS INVESTIGATION MAY BE REOPENED TO INCLUDE THE EVALUATION OF THE DEVICE. 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 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING CARDIAC ARRYTHMIA AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS SECTION ALSO ADDRESSES ALL PUMP PARAMETERS. SECTION 4 OF THE IFU, ¿SYSTEM MONITOR¿, DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. PER DESIGN, WHEN THE ESTIMATED FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LPM, A LOW FLOW STATUS IS POSTED TO THE LOG FILE. IF THE FLOW REMAINS BELOW 2.5 LPM FOR 10 SECONDS, A LOW FLOW HAZARD ALARM IS TRIGGERED. SECTION 4 ALSO EXPLAINS THAT CHANGES IN PATIENT CONDITION CAN RESULT IN LOW FLOW. SECTION 4 OF THE IFU ALSO STATES THAT THE PUMP STOP BUTTON CAN BE USED TO TURN OFF THE PUMP. TO USE THIS FEATURE, PRESS AND HOLD THE PUMP STOP BUTTON WHILE THE PUMP STOP COUNTDOWN COUNTS DOWN FROM 10 TO 1 THEN A STOPPING PUMP MESSAGE WILL BE DISPLAYED. THIS SECTION FURTHER STATES THAT THE PUMP STOPS WITHIN THE FIRST FEW SECONDS OF HOLDING DOWN THE PUMP STOP BUTTON. HOWEVER, IF THE BUTTON IS RELEASED BEFORE THE COUNTDOWN IS COMPLETE, THE PUMP RESUMES AT THE PREVIOUSLY SET MODE AND SPEED. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, PROVIDES INFORMATION ON ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. A SECTION ON ¿HANDLING EMERGENCIES¿ IS ALSO PROVIDED IN THE PATIENT HANDBOOK. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT WAS IN THE CATHETER LAB FOR AN IMPLANTABLE CARDIO DEFIBRILLATOR (ICD) LEAD PLACEMENT. THE PATIENT WAS RECEIVED INTRAVENOUS ANESTHESIA WHEN THE PATIENT COMPLAINED OF CHEST PAIN. THE PATIENT THEN CODED. LOW FLOW EVENTS WERE OBSERVED STARTING ON (B)(6) 2023 AT 03:09PM. THE PUMP SPEED WAS CHANGED AND THEN THE PUMP WAS INTENTIONALLY STOPPED AND RESTARTED. THERE WAS NO FLOW GOING THROUGH THE PUMP AT VARIOUS TIMES. AN EXTRACORPOREAL MEMBRANE OXYGENATOR (ECMO) WAS PLACED DURING THE RESUSCITATION EFFORTS. THE PATIENT'S HEMOGLOBIN WAS 10 BEFORE CODING AND 5 DURING THE CODE. ULTIMATELY THE PATIENT PASSED AWAY. AN AUTOPSY WAS PERFORMED, AND THE PUMP WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2342344 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 9049653 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Death