BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFINITY NT BALANCE

    MDR report key: 19236475 · Received May 3, 2024

    Report

    Report Number
    2184009-2024-00275
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    April 13, 2024
    Report Date
    May 30, 2024
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K191444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BK
    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

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THIS ISSUE HAS NOT OCCURRED BEFORE AT THE SITE. A MITRAL AND TRICUSPID VALVE REPLACEMENT PROCEDURE WAS BEING PERFORMED. THE PATIENT HAD NO COMORBIDITIES. THE PATIENT WAS NOT OPERATED ON THAT DAY, BUT FEW DAYS LATER WITH A DIFFERENT OXYGENATOR. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS NOT USED. IT WAS REPORTED THAT NO BLOOD CLOTTING WAS OBSERVED IN THE OXYGENATOR (ACT 665",PLT91) WHICH MEANS THAT THERE WAS NO THROMBOSIS OF THE OXYGENATOR. THE PATIENT WAS ON ANTICOAGULANT THERAPY. THE VENOUS AND CARDIOPLEGIA FLOW RATE WAS 4.7 LPM. THE CONFIGURATION WAS A ROLLER PUMP (A-V) ROLLER. A CELL SAVER WAS USED, BUT THE BLOOD DID NOT RETURN TO THE CARDIOTOMY VENOUS RESERVOIR (CVR), THE LEVEL IN THE CVR WAS BETWEEN 600-800 ML. DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWS EVIDENCE OF USE. PRESSURE INTEGRITY TESTING 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. TESTING WAS CONDUCTED AT A 1:1 RATIO (7LPM BLOOD AND GAS FLOWS) THE RESULTS AS REPORTED BELOW: 405 ML/MIN 02 XFERC , 277 ML/MIN CO2 XFERC 109 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. 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 AN AFFINITY NT OXYGENATOR, IT WAS REPORTED THAT WHEN STARTING ON EKC, THERE WAS A DROP IN THE OXYGEN SATURATION (SAO2) AFTER A VERY SHORT TIME. HOWEVER, THE SAO2 RETURNED TO NORMAL AND THE CUSTOMER SWITCHED TO TOTAL EKC AGAIN FROM THE SUPPORT OF THE MECHANICAL LUNG VENTILATION. THE SAO2 DROPPED AGAIN. THE CUSTOMER REPLACED THE OXYGENATOR TO CONTINUE THE PROCEDURE. THE EKC WAS STOPPED AND THE OXYGENATOR WAS CHANGED. AFTER THE CHANGE, IT MOVED TO THE EKC MACHINE AGAIN. ALTHOUGH THE DEVICE WAS REPLACED, THE SAO2 DROPPED AGAIN. THE CUSTOMER MADE THE DECISION TO ABANDON THE ENTIRE OPERATION AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306346 AFFINITY NT BALANCE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ PERFUSION SYSTEMS 511B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization