BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10761345 · Received October 30, 2020

    Report

    Report Number
    9611109-2020-00603
    Event Type
    Injury
    Date Received
    October 30, 2020
    Report Date
    September 30, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.10: BASED ON FOLLOW UP COMMUNICATIONS, THE HEATER COOLER SYSTEMS 3T IS USE AT THE TIME OF THE SURGERY WAS 16S10694 AND HEATER COOLER SYSTEMS 1T WERE 16S280, 16S1662, 16S278, 16S1846 AND 16S1845. IT WAS STATED THAT IT IS NOT KNOWN WHICH DEVICE WAS USED DURING THE RELEVANT SURGERY. NONE OF THE DEVICES USED AT THE TIME IS CURRENTLY IN OPERATION. REPORTEDLY, IN 2013, CLEANING AND DISINFECTION TOOK PLACE IN ACCORDANCE WITH THE MANUFACTURER'S INSTRUCTIONS VALID AT THE TIME. IT WAS ALSO REPORTED THAT THE DEVICES WERE POSITIONED WITHIN THE OPERATION THEATRE WITH THE AIR OUTLET DIRECTED AWAY FROM THE SURGERY FIELD. THE DISTANCE BETWEEN THE DEVICE AND THE SURGERY FIELD WAS ESTIMATED TO BE THREE (3) METERS. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    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). LIVANOVA INITIATED AN INVESTIGATION. 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 A REPORT STATING THAT IN 2013 A PATIENT UNDERWENT AN OPERATION USING A HYPOTHERMIC DEVICE FROM THE MANUFACTURER SORIN. IT IS UNKNOWN IF THE DEVICE WAS A 1T OR A 3T SYSTEM. LIVANOVA RECEIVED KNOWLEDGE THAT THE (B)(6) PROVIDED EVIDENCE OF M. CHIMAERA IN THE PATIENT AS PART OF THE DIAGNOSIS THERE IN (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231435 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other