BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIFUGAL PUMP CONSOLE

    MDR report key: 10406406 · Received August 14, 2020

    Report

    Report Number
    9611109-2020-00463
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    July 16, 2020
    Report Date
    July 16, 2020
    Manufacturer
    LIVANOVA DUTSCHLAND GMBH
    Product Code
    KFM
    PMA / PMN Number
    K020571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.10: A REVIEW OF THE DHR COULD NOT IDENTIFY ANY DEVIATIONS OR NONCONFORMITIES RELEVANT TO THE ISSUE. A LIVANOVA FIELD SERVICE ENGINEER WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. RESULTS REVEALED AN EPROM MEMORY FAILURE. THE EPROM IS MOUNTED ON THE PROCESSOR BOARD THUS, THIS COMPONENT WAS REPLACED TO SOLVE THE PROBLEM. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP CONSOLE. THE INCIDENT OCCURRED IN (B)(6). LIVANOVA INITIATED AN 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 RECEIVED A REPORT STATING THAT DURING A CASE CUSTOMER RECEIVED AN E2 AND HAD TO HAND CRANK. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870191 CENTRIFUGAL PUMP CONSOLE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM LIVANOVA DUTSCHLAND GMBH 60-03-00

    Patients

    Seq Age Sex Outcome Treatment
    1