BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIFUGAL PUMP 5 (CP5)

    MDR report key: 18309144 · Received December 12, 2023

    Report

    Report Number
    9611109-2023-00633
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    October 27, 2023
    Report Date
    March 25, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWA
    UDI-DI
    04033817902782
    PMA / PMN Number
    K112225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE CENTRIFUGAL PUMP 5 (CP5). THE INCIDENT OCCURRED IN PORTLAND, OREGON. THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THERE WAS AN INTERMITTENT ERROR (UNKNOWN CODE) WHEN TURNING DOWN FLOW ON CP5. A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND IN ORDER TO SOLVE THE ISSUE SHAFT ENCODER AND COMPUTER (HKR) BOARD WERE REPLACED. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. THIS REPORT WAS DUE ON NOVEMBER 26, 2023; HOWEVER, DUE TO A NETWORK DISRUPTION AT LIVANOVA, THE ABILITY TO SUBMIT MDRS WAS LOST ON NOVEMBER 19, 2023, BEFORE THIS REPORT WAS READY TO SUBMIT. THE REPORT WAS PREPARED AND SUBMITTED IMMEDIATELY FOLLOWING RESTORATION OF THE LIVANOVA SYSTEMS. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    BASED ON THE ANALYSIS OF THE CP5 SYSTEM SERVICE MANUAL (CP_SEM_60-00-60), SEVERAL ERROR MESSAGES ARE ASSOCIATED TO A FAULT IN THE MAIN PROCESSOR OF THE CIRCUIT BOARD HKR 0325 OR IN THE SHAFT ENCODER. THE ANALYSIS OF THE COMPLAINT DATABASE DID NOT REVEAL SIMILAR EVENTS RELATED TO THE INVOLVED CP5 SYSTEM SINCE 2021 (MFG DATE). BASED ON ALL THE CURRENT LEVEL OF INFORMATION, THE ROOT CAUSE OF THE EVENT WAS TRACED BACK TO A MALFUNCTION OF THE HKR BOARD AND SHAFT ENCODER. THE WEARING OF ELECTRO-MECHANICAL DEVICES CAN BE ORIGINATED BY THE SPECIFIC USE CONDITION AT CUSTOMER SITE THAT MAY HAVE CONTRIBUTED TO THE EVENT, SUCH AS MOVEMENTS OR LIQUIDS PENETRATION. HOWEVER, THERE IS NO CONCERNING TREND FOR THIS KIND OF FAILURE. FAILURE OF ELECTRONIC BOARDS CAN BE RELATED TO MULTIPLE AND NOT DETERMINISTIC FACTORS SUCH AS EXPOSURE TO HEAT, DUST AND MOISTURE, ACCIDENTAL IMPACTS (DROPS AND FALLS), AND POWER OVERLOADS/SURGES BUT ALSO TO VARIABILITY OF MICRO SUBCOMPONENTS. HOWEVER, THERE IS NO CONCERNING TREND FOR THIS KIND OF FAILURE. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A CENTRIFUGAL PUMP 5 (CP5) STOPPED DURING PROCEDURE WHEN TURNING DOWN FLOW. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303426 CENTRIFUGAL PUMP 5 (CP5) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA LIVANOVA DEUTSCHLAND 60-02-60Z 04033817902782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown