BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 11019101 · Received December 16, 2020

    Report

    Report Number
    9611109-2020-00684
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    July 17, 2019
    Report Date
    December 10, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    K191402
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. 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). THROUGH FOLLOW-UP COMMUNICATION WITH THE CHIEF PERFUSIONIST UNDER PREVIOUS CASES FROM THIS HOSPITAL, LIVANOVA (B)(4) LEARNED THAT THE WATER IN THE HEATER-COOLER SYSTEMS 3T IN USE IS CHANGED EVERY DAY AND THEY ARE STORED DRY. THIS IS NOT IN ALIGNMENT WITH CURRENT INSTRUCTION FOR USE HOWEVER REPORTEDLY THE DEVICES IN USE AT THE HOSPITAL ARE VERY CLEAN AND THERE IS NO SIGN OF BIOFILM. THE DEVICES ARE LOCATED INSIDE THE OPERATING THEATRE DURING USE. THE SERIAL NUMBERS OF THE DEVICE USED FOR THIS SURGERY IS UNKNOWN. HOWEVER, TWO (2) OVER FIVE (5) DEVICES USED AT THE HOSPITAL RESULTED TO BE CONTAMINATED. ONLY ONE SERIAL NUMBER HAS BEEN PROVIDED (B)(4) AND A FOLLOW UP REPORT FOR THE OTHER CASES ASSOCIATED TO THIS SPECIFIC DEVICE HAS BEEN FILED. THE SECOND SERIAL NUMBER REMAINS UNKNOWN AS WELL AS THE TYPE OF CONTAMINATION. 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 RECEIVED A REPORT THAT A FEMALE PATIENT UNDERGONE CARDIAC SURGERY ON (B)(6) 2019 AND AN HEATER-COOLER SYSTEM 3T WAS USED. THE PATIENT WAS THEN CONFIRMED TO BE INFECTED WITH MYCOBACTERIUM. THIS EVENT WAS INITIALLY CAPTURED UNDER IMPORTER REPORT NUMBER (B)(4) AND MANUFACTURER REPORT NUMBER 9611109 -2020 -00374 AND THEN SPLITTED FOLLOWING TO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488471 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O