BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10799728 · Received November 6, 2020

    Report

    Report Number
    9611109-2020-00622
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Report Date
    November 2, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO KNOWN PATIENT INVOLVEMENT. 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: K191402). LIVANOVA (B)(4) IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF HEATER-COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T . THE INCIDENT OCCURRED IN (B)(6). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THROUGH FOLLOW UP COMMUNICATION UNDER A PREVIOUS CASE FROM THE SAME HOSPITAL, LIVANOVA (B)(4) LEARNED THAT THE DEVICE WAS CLEANED REGULARLY PER THE IFU, PLACED INSIDE OF THE OPERATION THEATER DURING USE, WITH THE FAN FACING AWAY FROM THE PATIENT IN DIRECTION OF AN EXHAUST FAN IN THE WALL. THE DEVICE WAS KEPT IN A HOUSING WITH NEGATIVE PRESSURE IN RELATION TO THE PRESSURE IN THE OPERATING ROOM. THE ESTIMATED DISTANCE BETWEEN THE SURGERY FIELD AND THE DEVICE IS THREE (3) METERS.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED REPORT (B)(4) FROM (B)(6) STATING THAT A HEATER-COOLER SYSTEM 3T DEVICE WAS FOUND TO BE CONTAMINATED WITH MYCOBACTERIUM CHIMAERA (SAMPLE FROM (B)(6) 2020). THE LABORATORY REPORT CONFIRMING THE REPORTED CONTAMINATION HAS BEEN PROVIDED TO LIVANOVA. THERE IS NO KNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269252 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1