BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CP5 DRIVE UNIT

    MDR report key: 17058512 · Received June 5, 2023

    Report

    Report Number
    9611109-2023-00252
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    May 8, 2023
    Report Date
    August 25, 2023
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWA
    UDI-DI
    04033817900948
    PMA / PMN Number
    K112225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD SERVICE TECHNICIAN DISPATCHED TO THE FACILITY CONFIRMED THE ISSUE AND SOLVED IT BY REPLACING THE CP5 DRIVE UNIT. ALL FUNCTIONAL TESTS POSITIVELY PASSED AND THE UNIT WAS PUT BACK INTO SERVICE. COMPLAINTS DATABASE ANALYSIS REVEALED NO SIMILAR EVENT SINCE UNIT INSTALLATION IN 2021. BASED ON THE ABOVE, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT IS ONE THE FOLLOWING: DEFECTIVE CPU (HKR 0325) WHICH IS LOCATED IN CP5 PUMP CONTROL PANEL; DEFECTIVE CIRCUIT BOARD MOTOR CONTROL (ZPR 0801) WHICH IS LOCATED IN THE DRIVE UNIT; COMMUNICATION FAILURE BETWEEN CPU (HKR 0325) AND MOTOR CONTROL BOARD (ZPR 0801). THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE SORIN CENTRIFUGAL PUMP 5 (CP5). THE INCIDENT OCCURRED IN UNITED STATES. 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 · 0

    SEE INTIAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PROCEDURE, DESPITE THE RPM IN THE CP5 UNIT WERE FIXED, THEY OSCILLATED BETWEEN 500-600 RPM. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449209 CP5 DRIVE UNIT CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA LIVANOVA DEUTSCHLAND 60-01-04 04033817900948

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown