BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIFUGAL PUMP 5 (CP5)

    MDR report key: 12007728 · Received June 16, 2021

    Report

    Report Number
    9611109-2021-00321
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 16, 2021
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K112225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.10: BASED ON THE INFORMATION CURRENTLY AVAILABLE, AN HARDWARE FAILURE OF THE CENTRIFUGAL PUMP CAN BE EXCLUDED. IT CANNOT BE RULED OUT THAT AN HIGH PRESSURE IN THE ARTERIAL LINE WHICH CAN BE CAUSED BY HIGH PRESSURE AT THE OXYGENATOR, KINK IN THE CIRCUIT, CLOTS, PATIENT CLINICAL CONDITIONS, MAY HAVE LED TO A DECREASE IN THE CENTRIFUGAL PUMP SPEED.

    Additional Manufacturer Narrative · 0

    H10: NO INFORMATION RELATED TO THE PRESSURE PARAMETERS AND PUMP SHEET WERE PROVIDED EVEN IF REQUESTED. BASED ON THE CURRENTLY AVAILABLE INFORMATION, ON THE FACT THAT NO FAULTS COULD BE FOUND WHILE OPERATING THE CENTRIFUGAL PUMP AND THAT NO ISSUES WERE NOTICED ON THE DISPOSABLE REVOLUTION PUMP, IT CANNOT BE RULED OUT THAT THE REPORTED EVENT WAS DUE TO AN HIGH PRESSURE ISSUE AT THE OXYGENATOR OR CLINICAL/PATIENT CONDITIONS. REPORTEDLY, THE CUSTOMER IS USING THE PUMP WITH NO ISSUES. 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 INITIAL REPORT.

    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 5 (CP5). THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD NOT CONFIRM THE REPORTED ISSUE. INVESTIGATION IS ONGOING. 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 REPORT THAT DURING A PROCEDURE THE SPEED OF A CENTRIFUGAL PUMP 5 (CP5) RAMPED DOWN AND THE USER INCREASED RPMS TO ACHIEVE THE DESIRED FLOW. THE CUSTOMER SWAPPED OUT THE SYSTEM TO RESOLVE THE ISSUE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909861 CENTRIFUGAL PUMP 5 (CP5) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA LIVANOVA DEUTSCHLAND 60-01-04

    Patients

    Seq Age Sex Outcome Treatment
    1