BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION HOLLOW FIBER OXYGENATOR

    MDR report key: 23766341 · Received December 10, 2025

    Report

    Report Number
    9617601-2025-03327
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    December 5, 2025
    Report Date
    December 19, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K240666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    CORRECTION B5: IT WAS REPORTED THAT THE FUSION HOLLOW FIBER OXYGENATOR WAS ASSOCIATED WITH LOW FLOWS AT HIGH RPMS (REVOLUTIONS PER MINUTE), INDICATING A FLOW ISSUE THAT OCCURRED ALMOST IMMEDIATELY AFTER INITIATION OF CARDIOPULMONARY BYPASS. THERE WAS A POSSIBLE HIGH-PRESSURE EXCURSION (HPE). THE PATIENT HAD NOT PREVIOUSLY RECEIVED ANTICOAGULANT THERAPY OR BEEN ON HEPARIN. THE ISSUE DID NOT WORSEN OVER TIME. ANTI-COAGULATION WAS ASSESSED USING THE HEMOSTASIS MANAGEMENT SYSTEM (HMS), AND THE PRIMING SOLUTION INCLUDED HEPARIN AND MANNITOL. ALBUMIN WAS ADMINISTERED, WHICH RESULTED IN INCREASED FLOWS SUFFICIENT TO CONTINUE WITH THE PROCEDURE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. CORRECTION D1: UPDATED THE BRAND NAME CORRECTION D2: UPDATED THE PRODUCT CODE AND COMMON DEVICE NAME CORRECTION D3: UPDATED THE MANUFACTURER NAME AND ADDRESS CORRECTION D4: UPDATED THE MODEL AND CATALOG NUMBER ND THE LOT NUMBER INFORMATION CORRECTION G3: UPDATED THE PMA/ 510K NUMBER. 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 THE CUSTOM TUBING PACK WAS ASSOCIATED WITH LOW FLOWS AT HIGH RPMS (REVOLUTIONS PER MINUTE), INDICATING A FLOW ISSUE THAT OCCURRED ALMOST IMMEDIATELY AFTER INITIATION OF CARDIOPULMONARY BYPASS. THERE WAS A POSSIBLE HIGH PRESSURE EXCURSION (HPE). THE PATIENT HAD NOT PREVIOUSLY RECEIVED ANTICOAGULANT THERAPY OR BEEN ON HEPARIN. THE ISSUE DID NOT WORSEN OVER TIME. ANTI-COAGULATION WAS ASSESSED USING THE HEMOSTASIS MANAGEMENT SYSTEM (HMS), AND THE PRIMING SOLUTION INCLUDED HEPARIN AND MANNITOL. ALBUMIN WAS ADMINISTERED, WHICH RESULTED IN INCREASED FLOWS SUFFICIENT TO CONTINUE WITH THE PROCEDURE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316126 FUSION HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ PERFUSION SYSTEMS BB811 230024130

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown