BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 DOUBLE HEAD PUMP

    MDR report key: 7626047 · Received June 21, 2018

    Report

    Report Number
    9611109-2018-01059
    Event Type
    Malfunction
    Date Received
    June 21, 2018
    Date of Event
    May 9, 2018
    Report Date
    July 25, 2018
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWB
    UDI-DI
    04033817900405
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPLACED HKR PROCESSOR BOARD WAS RETURNED TO LIVANOVA (B)(4) FOR FURTHER INVESTIGATION. DURING EVALUATION OF THE RETURNED DEVICE, THE REPORTED FAILURE WAS REPRODUCED. THE ROOT CAUSE WAS DETERMINED TO BE ERRORS IN THE INTERNAL MEMORY BANK IN THE MICRO-CONTROLLER. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    LIVANOVA (B)(4) MANUFACTURES THE S5 DOUBLE HEAD PUMP. THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS ABLE TO CONFIRM THE REPORTED ISSUE AND REPLACED THE HKR PROCESSOR BOARD TO RESOLVE THE ERROR. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. THE REPLACED BOARD WAS REQUESTED FOR RETURN TO LIVANOVA (B)(4) FOR FURTHER INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT AN S5 DOUBLE HEAD PUMP DISPLAYED AN ERROR MESSAGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468877 S5 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB LIVANOVA DEUTSCHLAND 10-85-00 04033817900405

    Patients

    Seq Age Sex Outcome Treatment
    1