BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 8517330 · Received April 16, 2019

    Report

    Report Number
    9611109-2019-00253
    Event Type
    Death
    Date Received
    April 16, 2019
    Date of Event
    February 17, 2019
    Report Date
    June 21, 2019
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW UP COMMUNICATION LIVANOVA DEUTSCHLAND LEARNED, THAT THE HOSPITAL RE-USED SINGLE-USE HEATING BLANKETS UNTIL 18TH OF MARCH 2019. AS OF THIS DAY THE HOSPITAL HAS CHANGED THE APPROACH AND USE THE SINGLE USE HEATING BLANKETS AS SINGLE USE ONLY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    FURTHER PATIENT INFORMATION WAS NOT PROVIDED. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K052601). AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. LIVANOVA DEUTSCHLAND IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF HEATER-COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    LIVANOVA DEUTSCHLAND IDENTIFIED TWO NEWSPAPER ARTICLES THAT ARE REFERING TO THE SAME EVENT, IN WHICH IT IS STATED THAT A (B)(6) WOMAN, WHO DIED ON (B)(6) 2019 AT THE (B)(6) HOSPITAL, WAS OPERATED ON IN THE SUMMER OF 2018 AT THE (B)(6). ALLEGATION WAS MADE TOWARDS AN INFECTION WITH MYCOBACTERIUM CHIMAERA, WHILE NO NAME OF THE CONCOMITANT MACHINE OR THE COMPANY´S NAME WAS MENTIONED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313601 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 Death