BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER 3T SYSTEM

    MDR report key: 24321307 · Received February 12, 2026

    Report

    Report Number
    9611109-2026-90046
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    January 9, 2026
    Report Date
    May 25, 2026
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. D4. THE SERIAL NUMBER IS CURRENTLY NOT AVAILABLE. G5. 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. THE DEVICE MANUFACTURING DATE IS CURRENTLY NOT AVAILABLE. H.11 LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN UNITED KINGDOM. THROUGH FOLLOW-UP COMMUNICATIONS, IT WAS LEARNED THAT DEVICE CARDIOPLEGIA CIRCUIT HAD NOT YET BEEN FULLY TURNED OFF. INDEED, SINCE FLOW WAS STILL PRESENT, SUPPORT TO ANOTHER MEMBER OF THE MEDICAL TEAM TO CLOSE THE CARDIOPLEGIA LINE WITH THE RED STOPCOCK WAS ASKED. SUPPORT WAS NOT GIVEN AND, THEREFORE, TO PREVENT THE OUTWARD FLOW OF WATER FROM UNIT, A HAND THUMB WAS USED TO ATTEMPT TO STOP THE DRAINAGE. THIS DID NOT GET THE DESIRED EFFECT AND WATER STARTED TO SPRAY ACROSS THE OPERATING FIELD. REPORTEDLY, PATIENT WAS MOVED TO THE CUSTOMERS RECOVERY AREA AND NO FURTHER ISSUES HAVE BEEN DETECTED. THE AFFECTED DEVICE WAS REMOVED FROM SERVICE INITIALLY, HOWEVER, AFTER SUCCESSFULLY PASSING FUNCTIONAL VERIFICATION CHECKS CARRIED OUT BY THE CUSTOMER, THE UNIT HAS NOW RETURNED TO SERVICE IN ITS EXPECTED FUNCTION. 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

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, POST-PROCEDURE, AFTER THE PATIENT HAD BEEN DISCONNECTED FROM THE HEART-LUNG MACHINE, AND WHILE THE SURGICAL TEAM BEGAN DETACHING THE CARDIOPLEGIA HEATER-COOLER TUBING FROM THE HEAT EXCHANGER AND OXYGENATOR IN THE OPERATING THEATRE, WATER SPRAYED FROM THE HEATER COOLER 3T SYSTEM CARDIOPLEGIA CIRCUIT ACROSS THE OPERATING FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13128 HEATER-COOLER 3T SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH HEATER COOLER 3T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown