BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 9680292 · Received February 7, 2020

    Report

    Report Number
    9611109-2020-00062
    Event Type
    Injury
    Date Received
    February 7, 2020
    Report Date
    February 6, 2020
    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 · 0

    H.10: FURTHER INFORMATION HAS BEEN REQUESTED TO THE HOSPITAL IN ORDER TO CONFIRM/DENY THE NEWS. DESPITE THE ATTEMPTS, THE HOSPITALS DID NOT PROVIDE ANY FEEDBACK TO LIVANOVA. THUS, NO FURTHER INVESTIGATION IS POSSIBLE.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    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 AND 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 (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). 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

    THROUGH MEDIA MONITORING LIVANOVA LEARNED OF AN INFECTION OF A PATIENT WITH M.CHIMAERA. IN THE PAPER ARTICLE IT IS STATED THAT THE PATIENT HAD STARTED TO FEEL ILL DURING 2019 SHOWING INCREASING WEAKNESS, A HIGH WEIGHT LOSS, SOME FEVER. THE INFECTED PATIENT, HOSPITALIZED IN THE LAST FEW MONTHS AT (B)(6), HAS NOW BEEN DISCHARGED TO CONTINUE ANTIBIOTIC THERAPY AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143943 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1