BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S5 SYSTEM

    MDR report key: 13869377 · Received March 23, 2022

    Report

    Report Number
    9611109-2022-00126
    Event Type
    Injury
    Date Received
    March 23, 2022
    Date of Event
    February 3, 2022
    Report Date
    March 23, 2022
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. LIVANOVA (B)(4) MANUFACTURES THE S5 SYSTEM. THE INCIDENT OCCURRED IN (B)(6). LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND AFTER RESTARTING THE SYSTEM FEW TIMES IT WAS VERIFIED TO BE PROPERLY WORKING. A MEDICAL ASSESSMENT OF THE REPORTED EVENT HAS BEEN PERFORMED. THE RESULTS OF THE ASSESSMENT ARE THAT "PATIENT CRASHED" MEANS THAT HEMO-DYNAMIC PROBLEM WAS NOT SOLVED BY DRUGS ADMINISTRATION WITH THE CONSEQUENT NEED TO SUPPORT THE PATIENT AGAIN. PATIENT CRASHES CAN OCCUR REGARDLESS THE BYPASS IS SUCCESSFUL OR NOT. HOWEVER, IN THIS SPECIFIC CASE, IT CANNOT BE EXCLUDED THAT THE CASCADE OF USER ERRORS CONTRIBUTED TO PATIENT CRASH. IN THIS CASE, THE NEED TO GO BACK ON TO BYPASS WAS DUE TO A MISUSE PROBLEM AS SPECIFIED ABOVE. THUS, LIVANOVA CONCLUDES THAT THERE IS NO RELATIONSHIP BETWEEN THE REPORTED EVENT AND LIVANOVA DEVICE MALFUNCTION AND THAT THE REPORTED EVENT WAS SOLELY CAUSED BY USER ERROR. 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

    LIVANOVA RECEIVED REPORT THAT DURING A PROCEDURE THE FOLLOWING SEQUENCE OF EVENTS OCCURRED: B-CARE ICON WAS CROSSED OUT: B-CARE 5 WAS SWITCHED OFF ON THE SYSTEM PANEL (USER ERROR). S5 SYSTEM SHUT DOWN DURING BYPASS DUE TO S5 DOOR SLAMMED BY USER, LEADING THE CONSOLE TO SHUT DOWN (USER ERROR) AND USER PERFORMED HAND CRANK. THE S5 SYSTEM WAS TURNED BACK ON ARTERIAL PUMP (1) WAS NOT COMPLETING SELF TEST AFTER CONSOLE BEING TURNED ON DUE TO USER HAND CRANKING THE PUMP WITHOUT PUMP BEING SWITCHED OFF (USER ERROR) AND CHANGED IT WITH ANOTHER PUMP (2). CARDIOPLEGIA PUMP WAS NOT RUNNING IN AUTOMATIC MODE. THE CARDIOPLEGIA PUMP STOP-LINKED WITH ARTERIAL PUMP 1, WHICH WAS NO LONGER USED ON THE CONSOLE. THUS, THE CARDIOPLEGIA PUMP WAS NOT LINKED TO THE ARTERIAL PUMP 2 (USER ERROR). LEVEL AND BUBBLE ALARM DID NOT STOP THE ARTERIAL PUMP (2) SINCE LEVEL AND BUBBLE MONITORING FUNCTION HAD BEEN LINKED TO THE ARTERIAL PUMP 1, WHICH WAS NO LONGER USED ON THE CONSOLE (USER ERROR). NO SERIOUS INJURY WAS REPORTED AND ALL THE ABOVE FAILURES WERE SOLELY CAUSED BY USER ERRORS. IT WAS REPORTED THAT THE CASE WAS COMPLETED SUCCESSFULLY, INCLUDING NEEDING TO GO BACK ON TO BYPASS WHEN THE PATIENT CRASHED. AS PER LIVANOVA INTERPRETATION THE NEED TO GO BACK ON TO BYPASS IS A MEDICAL INTERVENTION TO PRECLUDE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726802 S5 SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND 48-40-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown