BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19767045 · Received July 17, 2024

    Report

    Report Number
    2916596-2024-04592
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    July 6, 2024
    Report Date
    October 8, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    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 COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED LOW FLOW ALARMS COULD NOT BE CONFIRMED THROUGH THE SUBMITTED LOG FILES. A SPECIFIC CAUSE FOR THE REPORTED ALARMS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, REVIEW OF THE SUBMITTED LOG FILES REVEALED A TRANSIENT INCREASE IN ROTOR NOISE VALUES. THESE FAULTS RESOLVED QUICKLY, AND NO FURTHER RELATED EVENTS WERE OBSERVED. A SPECIFIC CAUSE FOR THE CHANGE IN ROTOR PARAMETERS COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE CONTROLLER EVENT LOG FILES CONTAINED EVENTS FROM 04JUL2025 THROUGH 06JUL2024. ONE MOTOR INSTABILITY LEFT VENTRICULAR ASSIST DEVICE (LVAD) FAULT FLAG WAS CAPTURED ON 06JUL2024 THAT RESOLVED ON ITS OWN. THE LVAD EVENT LOG FILES CONTAINED EVENTS FROM 05JUL2024 THROUGH 06JUL2024. AN INCREASE IN ROTOR NOISE, RESULTING IN ROTOR NOISE FAULTS, WAS OBSERVED ON 06JUL2024. SHORTLY AFTER, ROTOR NOISE VALUES RETURNED TO BASELINE AND NO FURTHER RELATED EVENTS WERE OBSERVED. NO OTHER NOTABLE EVENTS WERE OBSERVED, AND THE PUMP APPEARED TO HAVE OPERATED AS INTENDED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED BY THE ACCOUNT. THE PATIENT REMAINS ONGOING ON HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-042494. NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-042494 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) REV. C, AND THE HEARTMATE 3 PATIENT HANDBOOK REV. D, ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, ADDRESSES ALL PUMP PARAMETERS, INCLUDING PUMP FLOW. SECTION 4 OF THE IFU, ¿SYSTEM MONITOR¿, DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS AND EXPLAINS THAT CHANGES IN PATIENT CONDITION CAN RESULT IN LOW FLOW. PER DESIGN, WHEN THE ESTIMATED FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LITERS PER MINUTE (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 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. FURTHERMORE, 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 CAUTIONS THE USERS TO CALL THEIR HOSPITAL CONTACT 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. 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 ONE LOW FLOW ALARM THAT WAS NOT SEEN ON THE MONITOR. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED CLUSTERS OF PULSATILITY INDEX (PI) EVENTS. THE LOG FILES ALSO CAPTURED A TRANSIENT INTERNAL MOTOR INSTABILITY FAULT ON (B)(6)2024 AT 4:57 AM WHICH APPEARED TO HAVE SELF-RESOLVED. NO LOW FLOWS WERE CAPTURED IN THE LOG FILES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362533 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 10248326 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown