BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXY/CVR COMBO BB841 FUSION W/BALANCE 26L

    MDR report key: 23591277 · Received November 19, 2025

    Report

    Report Number
    2184009-2025-01495
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 12, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K240666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FOR THE THE EVENT STATED THAT THE FIBRIN WAS OBSERVED IN CARDIOTOMY VENOUS RESERVOIR AND NOT THE FUSION OXYGENATOR, BASED ON COMPLAINT HISTORY AND RISK ANALYSIS, THE CHANCE OF FIBRIN RESULTING IN A DEATH OR SERIOUS INJURY IF THIS PRODUCT EVENT WERE TO RECUR, IN THIS DEVICE OR A SIMILAR DEVICE, IS REMOTE. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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 D1. BRAND NAME, 4. MODEL # , 4.1 CATALOG #: THESE FIELDS WERE UPDATED. 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

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED THAT THERE WAS FIBRIN FORMATION INSIDE THE RESERVOIR. THE USE OF THE DEVICE WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT HAD A DOUBLE CORONARY ARTERY BYPASS GRAFT (CABG) AND A MITRAL VALVE REPLACEMENT (MVR). CEZOL 1GR, NEVPARIN 10000IU, ISOLYTE S 1000CC, GELOFUSINE 500CC AND MANNITOL 100CC WERE USED IN PRIME OR DURING THE CASE. THE TEMPERATURES OF THE ARTERIAL AND VENOUS LINE OF THE OXYGENATOR WERE 30 AND 31 RESPECTIVELY. THE FIBRIN WAS LOCATED AT THE VENOUS RESERVOIR 1000CC LEVEL LINE TO THE RIGHT OF THE 600CC LEVEL LINE REGION. THE FIBRIN GREW SLOWLY. THERE WAS NO AIR ENTERING THE RESERVOIR RELATED TO TABLE MANNERS. STANDARD SURGICAL PRACTICE WAS NOT DEVIATED FROM. KPD WAS CHECKED AT THE BEGINNING AND EVERY 30 MINUTES. THE ACT (ACTIVATED CLOTTING TIME) VALUE WAS 441S PRE-CARDIOPULMONARY BYPASS (CPB). THE ACT VALUE WAS 579S DURING INITIAL CPB. THE ACT VALUE WAS 734S AND 675S AT THE 30TH AND 60TH MINUTE ON CPB, RESPECTIVELY. THERE WAS NO BLOOD PRODUCT USED. DELNIDO CARDIOPLEGIA WAS ADMINISTERED. THE HCT (HEMATOCRIT) VALUE WAS 33 PRE-CPB. THE HCT VALUE WAS 23 DURING ADMISSION OF CPB. THE HCT VALUE WAS 23 AND 36 AT THE 30TH AND 60TH MINUTE ON CPB, RESPECTIVELY.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR DEVICE, IT WAS REPORTED THAT THERE WAS FIBRIN FORMATION INSIDE THE OXYGENATOR. THE USE OF THE DEVICE WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290058 OXY/CVR COMBO BB841 FUSION W/BALANCE 26L OXYGENATOR, CARDIOPULMONARY BYPASS DTZ PERFUSION SYSTEMS BB841 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown