BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CP5 FLOW MODULE

    MDR report key: 19771547 · Received July 18, 2024

    Report

    Report Number
    9611109-2024-00320
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 19, 2024
    Report Date
    September 23, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA FIELD SERVICE REPRESENTATIVE CHECKED THE SYSTEM AND FOUND THAT THE FLOW SENSOR WAS NOT WORKING (NO FLOW WAS DISPLAYED). SERIAL NUMBER OF DEFECTIVE FLOW SENSOR COULD NOT BE RETRIEVED SINCE NOT FULLY READABLE. AS TROUBLESHOOTING, FLOW SENSOR WAS REPLACED WITH SN (B)(6) AND THE FLOW REAPPEARED. BASED ON COLLECTED INFORMATION, THE ROOT CAUSE OF THE ISSUE CAN BE TRACED BACK TO A FAULTY FLOW SENSOR, MOST LIKELY DUE TO WEARING OF ITS ELECTRONICS. THE WEARING OF ELECTRO-MECHANICAL DEVICES CAN BE ORIGINATED BY THE SPECIFIC USE CONDITION AT CUSTOMER'S SITE AND MAY HAVE CONTRIBUTED TO THE EVENT. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET. SINCE THE ISSUE IS PROMPTLY DETECTABLE (NO FLOW IS DISPLAYED) THE CUSTOMER CAN READILY REACT AND INSTALL A FLOW SENSOR. THEREFORE THERE IS UNLIKELY POSSIBILITY TO CAUSE ANY PATIENT INJURY. THE EVENT HAS BEEN REASSESSED AS NOT REPORTABLE.

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT INVOLVEMENT. THE UNIQUE IDENTIFIER (UDI) NUMBER HAS NOT BEEN PROVIDED BY THE ORIGINAL EQUIPMENT MANUFACTURER. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. . THE CP5 FLOW MODULE 25-60-70Z IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO CP5 FLOW MODULE 25-60-70, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K112225). H.4. AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. LIVANOVA DEUTSCHLAND MANUFACTURES THE FLOW SENSOR MEASUREMENT . THE INCIDENT OCCURRED IN FRANCE. 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

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT RELATED TO A FAULTY ARTERIAL FLOW INVOLVING THE CP5 FLOW MODULE. THE EVENT OCCURRED DURING PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501185 CP5 FLOW MODULE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA LIVANOVA DEUTSCHLAND 25-60-70Z

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown