BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CP5 CENTRIFUGAL PUMP

    MDR report key: 17963728 · Received October 19, 2023

    Report

    Report Number
    9611109-2023-00535
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    September 19, 2023
    Report Date
    February 6, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DTQ
    UDI-DI
    04033817901938
    PMA / PMN Number
    K210130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE CENTRIFUALG PUMP. THE INCIDENT OCCURRED IN FRANCE. A LIVANOVA FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. THE CPU CARD AND SWITCH CONTROL WERE SUBSTITUTED AND DEVICE RETURNED TO SERVICE. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H10: THE CONTROL BOARD (CPU HKR 0325) CONTROLS BOTH THE FUNCTION OF THE DISPLAY AND CORRESPONDING BOARD (HKD 0327) OF THE CONTROL PANEL AND THE FUNCTION OF THE DRIVE UNIT (MOTOR CONTROL BOARD ZKR 0801). THE PUSH BUTTON SWITCH IS A SMALL, SEALED MECHANISM THAT COMPLETES AN ELECTRIC CIRCUIT WHEN IT IS PRESSED. WHEN IT IS IN THE "ON" POSITION, A SMALL METAL SPRING INSIDE MAKES CONTACT WITH TWO WIRES, ALLOWING ELECTRICITY TO FLOW. WHEN IT'S OFF, THE SPRING RETRACTS, CONTACT IS INTERRUPTED, AND CURRENTLY DOES NOT FLOW. IF THE SWITCH DOES NOT PROPERLY LATCH, MOST LIKELY ITS INTERNAL SPRING IS FAULTY. A DEVICE SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND IDENTIFIED THAT THE UNIT WAS MANUFACTURED IN 2020 AND NO OTHER SIMILAR EVENT HAS BEEN REPORTED, NEITHER CONCERNING TREND HAS BEEN IDENTIFIED. BASED ON THE INFORMATION AVAILABLE AND ON TECHNICAL INTERVENTION DONE, THE MOST LIKELY ROOT CAUSES IDENTIFIED ARE THE FOLLOWING: - DEFECTIVE SPRING OF THE PUSH TOGGLE SWITCH THAT DID NOT PROPERLY LATCH AND CAUSED THE LOSS OF POWER OF THE TOTAL CP5 SYSTEM; - ELECTRICAL FAILURE OF THE CONTROL BOARD HKR 0325 SUCH AS DIRTY/OXIDIZED CONTACTS.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING PRIMING, CENTRIFUGAL PUMP DOES AND CONTROL PANEL STOP WORKING. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653070 CP5 CENTRIFUGAL PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND GMBH 60-00-60 04033817901938

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown