BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 17773445 · Received September 19, 2023

    Report

    Report Number
    9611109-2023-00447
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Report Date
    April 22, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    K191402
    Removal / Correction Number
    Z-0073-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 HEATER-COOLER SYSTEM 3T. 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.

    Additional Manufacturer Narrative · 0

    LIVANOVA HAS IDENTIFIED THAT QRG VERSION 22 CONTAINS INCONSISTENT INFORMATION REGARDING THE DISINFECTION CALENDAR TABLE IN PAGE 3 OF THE CURRENT USA QRG. THE INFORMATION ON THE QRG IS NOT ALIGNED WITH CURRENT USA VERSION OI OF 3T HEATER COOLER. MEDICAL DEVICE CORRECTION Z-0073-2024 (LIVANOVA REF FA-CP-MUN-2023-001) WAS DEPLOYED TO INFORM AFFECTED CUSTOMERS, REMOVE ALREADY DISTRIBUTED INCORRECT COPIES AND PROVIDE THE CORRECTED REVISION OF THE QRG. 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 HAS RECEIVED A REPORT THAT THE CALENDAR SUMMARY TABLE OF THE QUICK REFERENCE GUIDE INCLUDED IN SOME 3T HEATER COOLERS ARE NOT ALIGNED WITH 3T HEATER COOLER INSTRUCTIONS FOR USE. 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
    2096813 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown