BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 17081969 · Received June 7, 2023

    Report

    Report Number
    2916596-2023-03605
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    June 3, 2023
    Report Date
    June 28, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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

    MANUFACTURE¿S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED DRIVELINE POWER FAULT ALARMS; HOWEVER, A SPECIFIC CAUSE FOR THE ALARMS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED SYSTEM CONTROLLER LOG FILES CONFIRMED DRIVELINE POWER FAULT ALARMS THAT BECAME ACTIVE ON (B)(6)2023. THE PUMP APPEARED TO HAVE OPERATED AS INTENDED AT THE SET SPEED THROUGHOUT THE DURATION OF THE LOG FILES. THE EXCHANGED MODULAR CABLE WAS NOT RETURNED FOR EVALUATION. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ PROVIDES INSTRUCTION REGARDING HOW TO CARE FOR THE DRIVELINE IN A SUB-SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES." SECTION 7 ALSO OUTLINES SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THE HEARTMATE 3 LVAS PATIENT HANDBOOK SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ CONTAINS A SUBSECTION ENTITLED ¿WHAT NOT TO DO: DRIVELINE AND CABLES¿ WHICH CONTAINS INFORMATION REGARDING HOW TO CARE FOR THE DRIVELINE. SECTION 5 ALSO OUTLINES SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. SECTION 8 ENTITLED ¿HANDLING EMERGENCIES¿ LISTS EXAMPLES OF EMERGENCIES, INCLUDING DRIVELINE POWER FAULTS, AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THESE EMERGENCIES. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE MODULAR CABLE, LOT NUMBER 190297 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. 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 WAS EXPERIENCING DRIVELINE POWER FAULT ALARMS. THE LOG FILES CONFIRMED A DRIVELINE POWER FAULT ALARM ON (B)(6)2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ALARMS WERE ATTEMPTED TO BE CLEARED BUT THEY WOULD NOT RESOLVE. THE MODULAR CABLE WAS DETERMINED TO THE CAUSE OF THE ALARM AND WAS EXCHANGED ALONG WITH THE SYSTEM CONTROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481270 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525 190297 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male