BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 9408690 · Received December 4, 2019

    Report

    Report Number
    9611109-2019-00937
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    November 8, 2019
    Report Date
    December 3, 2019
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA, AND IT IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K052601). LIVANOVA (B)(4) IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF HEATER-COOLER DEVICES. THE Z NUMBER IS (B)(4). LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN UNKNOWN CITY. BASED ON THE CURRENT LEVEL OF INFORMATION, IT HAS NOT BEEN POSSIBLE TO IDENTIFY THE EVENT AND THE HOSPITALS WHERE THE SURGERIES TOOK PLACE. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW UP REPORT WILL BE FILED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED AN ANONYMOUS COMMUNICATION OF A MYCOBACTERIUM CHIMAERA INFECTION. THE PATIENT UNDERGONE 3 SURGERIES IN 3 DIFFERENT HOSPITALS. THE HOSPITALS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205483 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1