BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 24764737 · Received April 2, 2026

    Report

    Report Number
    9611109-2026-90133
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    August 31, 2015
    Report Date
    April 2, 2026
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: THE INFORMATION REGARDING SERIAL NUMBER OF THE DEVICE INVOLVED WAS UNCERTAIN AND AS A CONSEQUENCE IT IS NOT POSSIBLE TO DETERMINE THE UDI. G4: 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: K220635). H4: AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. H11: LEGAL LAWSUIT HAS BEEN INITIATED BY THE PLAINTIFF AGAINST THE HOSPITAL AND LIMITED INFORMATION HAS BEEN MADE AVAILABLE. RELEVANT PATIENT¿S MEDICAL HISTORY INCLUDED: CROHN'S DISEASE WHICH WAS DIAGNOSED IN 2013. CATARACT SURGERY AND THE INSERTION OF A LENS IN 2007. THE SERIAL NUMBER OF THE HEATER COOLER DEVICE USED DURING THE PROCEDURE HAS NOT BEEN IDENTIFIED. POSSIBLE SERIAL NUMBERS WERE (B)(6). IN THE ABSENCE OF A CONFIRMED SERIAL NUMBER, A COMPREHENSIVE DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR ALL HEATER COOLER SYSTEM 3T UNITS THAT WERE IN SERVICE AT THE HOSPITAL AT THE TIME OF SURGERY. THIS REVIEW DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED EVENT. ALTHOUGH THE SERIAL NUMBER OF THE SPECIFIC DEVICE USED DURING THE PROCEDURE REMAINS UNKNOWN, IT CAN BE CONFIRMED THAT IT WOULD NOT HAVE BEEN EQUIPPED WITH THE VACUUM AND SEALING KIT, AS THIS UPGRADE WAS INTRODUCED IN 2017. AT THE TIME OF PATIENT¿S SURGERY, WATER SAMPLING OF THE DEVICES WAS DONE ANNUALLY. ON (B)(6) 2015, LABORATORY WATER TESTING FROM (B)(6) 2015 (A MONTH BEFORE THE SURGICAL INTERVENTION) TESTED NEGATIVE FOR M. CHIMAERA. IN JULY 2016, RESULTS OF THE LABORATORY WATER TESTING WERE POSITIVE TO M. CHIMAERA. IN (B)(6) 2016, ALL HEATER COOLER SYSTEM 3T UNITS THAT WERE IN SERVICE AT THE HOSPITAL AT THE TIME OF SURGERY WERE REPLACED. NO DEVIATIONS FROM THE INSTRUCTIONS FOR USE WERE IDENTIFIED IN CUSTOMER¿S DEVICE CLEANING AND DISINFECTION PRACTICES AT THE TIME OF THE EVENT. SOURCE OF PATIENT CONTAMINATION REMAINS UNKNOWN AND ANY DIRECT INVOLVEMENT OF THE LIVANOVA DEVICE REMAINS UNDETERMINED. LIVANOVA HAS IMPLEMENTED A STRATEGY TO PROGRESSIVELY DECREASE THE PROBABILITY OF BACTERIA GROWTH IN THE HEATER COOLER DEVICE BY APPLYING MULTIPLE MEASURES IMPLEMENTED OVER THE PAST FEW YEARS THROUGH DEDICATED CORRECTIVE ACTIONS AND A FIELD ACTION. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SEE INITIAL REPORT: 9611109-2018-01284.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831025 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH HEATER COOLER 3T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown