BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER/COOLER 3T 120V/60 HZ

    MDR report key: 17388902 · Received July 25, 2023

    Report

    Report Number
    9611109-2023-00356
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Report Date
    April 22, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    UDI-DI
    04033817900528
    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 Professional
    N

    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 HAS 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 (B)(4)) 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 IFU. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947439 HEATER/COOLER 3T 120V/60 HZ CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH 16-02-85 04033817900528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown