BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION HOLLOW FIBER OXYGENATOR

    MDR report key: 23465058 · Received November 4, 2025

    Report

    Report Number
    2184009-2025-01413
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 6, 2025
    Report Date
    January 15, 2026
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K240666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWS NO OUTWARD SIGNS OF PHYSICAL DAMAGE OR ABNORMALITIES. UNIT APPEARS TO HAVE BEEN USED. PRESSURE INTEGRITY TE STING SHOWS NO INTERNAL OR EXTERNAL LEAKS WHEN RUN AT 3 LPM WITH 23 PSI, (1189 MMHG) OF BACK PRESSURE FOR 10 MINUTES. THE DEVICE WAS SENT TO THE BLOOD LAB FOR PERFORMANCE TESTING. THE TESTING WAS CONDUCTED AT A 1:1 RATIO (7LPM BLOOD <(>&<)> GAS FLOWS) THE RESULTS AS REPORTED BELOW: ¿ 301 ML/MIN 02 XFERC ¿ 203 ML/MIN CO2 XFERC ¿ 174 MM/HG DELTA PBLOOD REASON FOR RETURN WAS UNDETERMINED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING EXTRACORPOREAL CIRCULATION WITH THE FUSION OXYGENATOR, FLOW DROPPED AND RESISTANCE ROSE APPROXIMATELY ONE TO TWO MINUTES AFTER DEPARTURE AT 10.21 AM TO CARDIOPULMONARY BYPASS WITH A POST-ANTICOAGULANT ACT (ACTIVATED CLOTTING TIME) OF 370 SECONDS. THE CUSTOMER WAS NO LONGER ABLE TO ASSUME THE CIRCULATION EXTRA-CORPORELLE (CEC) CIRCUIT. THE CARDIAC SURGERY WAS A MITRAL VALVE REPLACEMENT REDUX. THE LATEST RECOMMENDATIONS INCLUDE THE ADDITION OF TWO SAX VAC FILTERS (1 ON VACUUM ASSISTED VENOUS DRAINAGE (VAVD) AND 1 ON WASTE ANESTHETIC GAS (WAG)). THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. IT WAS STATED THAT THE PATIENT IS STABLE BUT A DIAGNOSIS OF HEPARIN-INDUCED THROMBOCYTOPENIA (HIT) IS UNDERWAY. ANTI-VITAMIN K (AVK) WAS STOPPED 5 DAYS BEFORE THE OPERATION. THE PATIENT WAS UNDER UNFRACTIONATED HEPARIN (HÉPARINE NON FRACTIONNÉE (HNF)) 20,000UI/24H CURATIVE SINCE (B)(6) 2025. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE BLOCKAGE/FLOW ISSUE WAS IN THE OXYGENATOR. THERE WAS 1000ML OF ISOFUNDINE, 200ML OF RINGER LACTATE AND 1000 UI OF HEPARIN SODIUM USED DURING PRIME. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE WAG IS THE CO2 (CARBON DIOXIDE) EXTRACTION FROM THE OXYGENATOR TO THE CONSOLE VENTILATION MODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930895 FUSION HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ PERFUSION SYSTEMS BB811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female