BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 17788202 · Received September 21, 2023

    Report

    Report Number
    2916596-2023-06586
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    June 10, 2023
    Report Date
    September 21, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF LOW FLOW ALARMS WAS CONFIRMED THROUGH THE REVIEW OF THE SUBMITTED LOG FILES AS WELL AS THROUGH THE ON-SITE EVALUATION CONDUCTED BY ABBOTT REPRESENTATIVE; HOWEVER, A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE DETERMINED THROUGH THIS EVALUATION. THE CONTROLLER EVENT LOG FILE CONTAINED EVENTS FROM (B)(6) 2023. SEVERAL LOW FLOW ALARMS WERE CAPTURED ON (B)(6) 2023 AND (B)(6)2023, WHICH WERE ASSOCIATED WITH ELEVATED PULSATILITY INDEX (PI) VALUES. NO OTHER NOTABLE EVENTS WERE CAPTURED, AND THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE SET SPEED. IT WAS REQUESTED TO HAVE THE LOW FLOW ALARM THRESHOLD ADJUSTED TO 2.0 LITERS PER MINUTE (LPM) ON THE PATIENT¿S PRIMARY AND BACKUP SYSTEM CONTROLLERS, HSC-123092 AND HSC-121672. THE THRESHOLD ADJUSTMENT WAS SUCCESSFULLY COMPLETED ON 08 AUG 2023, WITHOUT ISSUE. ADDITIONALLY, SEVERAL PUMP RESET EVENTS WERE CAPTURED ON (B)(6) 2023 WHICH HAD CORRESPONDING DECREASES IN PUMP FLOW TO 0 LPM. FOLLOWING THESE EVENTS, THE PUMP RESUMED NORMAL OPERATION WITHOUT ISSUE. A SPECIFIC CAUSE FOR THESE FINDINGS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. NO OTHER NOTABLE EVENTS WERE CAPTURED, AND THE PUMP APPEARED TO FUNCTION AS INTENDED THROUGHOUT THE DURATION OF THE FILE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. 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 IFU, AND THE HEARTMATE 3 PATIENT HANDBOOK, ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, ADDRESSES ALL PUMP PARAMETERS. SECTION 1 STATES THAT ¿PI CALCULATION REPRESENTS CARDIAC PULSATILITY AND PI VALUES TYPICALLY RANGE FROM 1 TO 10. IN GENERAL, THE MAGNITUDE OF THE 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). LOWER VALUES INDICATE LESS VENTRICULAR FILLING AND LOWER PULSATILITY (I.E. THE PUMP IS PROVIDING GREATER SUPPORT AND FURTHER UNLOADING THE VENTRICLE)¿. 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. FOLLOWING SOFTWARE UPGRADES, THE HM3 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. 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. THESE DOCUMENTS ALSO WARN OF EVENTS THAT MAY CAUSE THE PUMP TO STOP AND HOW TO PREVENT PUMP STOPS FROM OCCURRING. 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 PATIENCE EXPERIENCED LOW FLOW ALARMS ON (B)(6) 2023. FURTHER LOG FILE REVIEW REVEALED THAT SEVERAL PUMP RESET EVENTS OCCURRED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447025 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8842505 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male