BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 17745510 · Received September 14, 2023

    Report

    Report Number
    2916596-2023-06629
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    August 30, 2023
    Report Date
    November 29, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED DRIVELINE POWER FAULT ALARMS; HOWEVER, A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE CONTROLLER EVENT LOG FILES COLLECTIVELY CONTAINED EVENTS FROM 30AUG2023 THROUGH 02SEP2023 AND FROM 12NOV2023 THROUGH 14NOV2023. DRIVELINE POWER FAULT ALARMS, ASSOCIATED WITH POWER A BROKEN FAULTS, WERE CAPTURED ON 30AUG2023, 01SEP2023, AND 02SEP2023. THE ALARMS WERE PERIODICALLY SILENCED. FOLLOWING THE OBSERVED SYSTEM CONTROLLER EXCHANGE ON 02SEP2023, NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED. DESPITE THE ALARMS, THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE SET SPEED. 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 MLP-031724, AND NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-031724 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 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, ADDRESSES ALL SYSTEM ALARM CONDITIONS, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, LISTS EXAMPLES OF EMERGENCIES, INCLUDING DRIVELINE POWER FAULTS, AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THESE EMERGENCIES. FURTHERMORE, THE PATIENT HANDBOOK INSTRUCTS THE USER 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBERS: 2916596-2023-06749 AND 2916596-2023-06740. IT WAS REPORTED THAT THE PATIENT'S LOG FILES REVEALED 16 DRIVELINE POWER FAULTS ON (B)(6) 2023, (B)(6) 2023, AND (B)(6) 2023. A RESOLUTION OF THE ALARMS WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED. THE ALARMS DID NOT RETURN. SYSTEM CONTROLLER CAPTURED UNDER MFR. REPORT # 2916596-2023-06740. MODULAR CABLE CAPTURED UNDER MFR. REPORT # 2916596-2023-06749.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2225817 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8372104 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male