BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIFUGAL PUMP CONSOLE

    MDR report key: 8821540 · Received July 24, 2019

    Report

    Report Number
    9611109-2019-00566
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    June 25, 2019
    Report Date
    July 24, 2019
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    KFM
    PMA / PMN Number
    K020571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP CONSOLE. THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE AND COULD CONFIRM THE REPORTED FAILURE SINCE THE SYSTEM WOULD NOT RESPOND TO ANY TOUCHSCREEN INPUT. HE REPLACED THE TOUCHSCREEN AND WAS THUS ABLE TO REMOVE THE ISSUE. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. 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 OF A CENTRIFUGAL PUMP CONSOLE WITH A NON-RESPONSIVE TOUCHSCREEN DURING PROCEDURE. THE USER SWITCHED THE PATIENT TO A BACK-UP SYSTEM. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616027 CENTRIFUGAL PUMP CONSOLE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM LIVANOVA DEUTSCHLAND 60-03-75

    Patients

    Seq Age Sex Outcome Treatment
    1