BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C5 SYSTEM

    MDR report key: 16349701 · Received February 10, 2023

    Report

    Report Number
    9611109-2023-00061
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 12, 2023
    Report Date
    February 9, 2023
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K093882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: DURING TROUBLESHOOTING AT CUSTOMER'S FACILITY, COMPUTER BOARD (HKR) WAS FOUND TO BE DEFECTIVE. THEREFORE, IT WAS REPLACED IN ORDER TO SOLVE THE ISSUE. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. BASED ON TECHNICAL SERVICE INTERVENTION DONE, IT CANNOT BE RULED OUT THAT THE REPORTED ISSUE WAS CAUSED BY AN ELECTRONIC FAILURE OF THE PUMP COMPUTER BOARD (HKR).

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA DEUTSCHLAND MANUFACTURES THE C5 SYSTEM. THE INCIDENT OCCURRED IN NITAI NAGAR, INDIA. A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE. CONNECTIONS OF MOTOR CONTROL AND MOTOR POWER AMPLIFIER BOARDS WERE CHECKED AND RE-FIXED WITHOUT ISSUE RESOLUTION. THERE WAS NO SIGN OF SPILLAGE ON BOARDS. SOFTWARE OF THE DEVICE WAS FLASHED TO A NEW VERSION, BUT THE ISSUE STILL REMAINED. IN ORDER TO FIX THE ISSUE, MOTOR CONTROL AND MOTOR POWER AMPLIFIER BOARDS NEED TO BE REPLACED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A PUMP ON A C5 HEART LUNG MACHINE GAVE AN ERROR MESSAGE RELATED TO A MOTOR CONTROL FAILED. THE ISSUE OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47287 C5 SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND 58-00-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown