BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 19733583 · Received July 12, 2024

    Report

    Report Number
    3003752502-2024-00023
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 26, 2024
    Report Date
    September 20, 2024
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    UDI-DI
    08034013782020
    PMA / PMN Number
    K141492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4 - LOT NUMBER: CORRECTED SECTION D4 - PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: FUNCTIONAL TESTING OF THE RETURNED OXYGENATOR BY THE EXTERNAL MANUFACTURER (EUROSETS) CONFIRMED AN OXYGENATOR LEAK DUE TO FIBER BREAKAGE; HOWEVER, A SPECIFIC ROOT CAUSE FOR THE FIBER BREAKAGE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE OXYGENATOR WAS FOUND TO HAVE A LEAK DURING CIRCUIT PRIMING WITHIN A MINUTE OF THE PRIMING SOLUTION FILLING THE CIRCUIT; IT WAS FLOWING AROUND 3 LITERS PER MINUTE AT 2500 REVOLUTIONS PER MINUTE (RPMS) WHEN THE LEAK WAS NOTICED. THE LEAK WAS NOTICED TO HAVE BEEN COMING FROM THE UNDERSIDE OF THE POST OXYGENATOR PORT FROM THE PLASTIC ITSELF. THE OXYGENATOR WAS REMOVED AND REPLACED WITH ANOTHER OXYGENATOR WITH THE SAME LOT NUMBER THAT DID NOT HAVE A VISIBLE LEAK AND WAS FINE BEING STORED IN THE PRIMED CIRCUIT. THE OXYGENATOR WAS RETURNED TO ABBOTT WHERE AN INITIAL VISUAL INSPECTION WAS PERFORMED. THE OXYGENATOR WAS THEN FORWARDED TO EUROSETS FOR TECHNICAL ANALYSIS. THE OXYGENATOR WAS PLACED ON A MOCK LOOP WITH PHYSIOLOGICAL WATER. THE OXYGENATOR WAS FILLED USING A PERISTALTIC PUMP AT 6 LITERS PER MINUTE AND REMAINED IN THE MOCK LOOP FOR 10 MINUTES. A SLOW DRIP IN THE LOWER PART OF THE OXYGENATOR WAS CONFIRMED. THE DEVICE WAS SECTIONED BY REMOVING THE LOWER HOUSING, REFILLED WITH WATER, AND PRESSURIZED. THE POINT OF LOSS OCCURRED DUE TO THE FIBER BREAKAGE OF THE LAST WINDING OF FIBERS NEAR THE BLOOD OUTLET PORT. THE DEVICE HISTORY RECORD FOR THE OXYGENATOR WAS REVIEWED BY THE EXTERNAL MANUFACTURER AND SHOWED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. DEVICES ARE REQUIRED TO PASS MANUFACTURING INSPECTIONS AND SPECIFICATIONS PRIOR TO RELEASE, AND NO ABNORMALITIES WERE DOCUMENTED WHICH WOULD CAUSE OR CONTRIBUTE TO THE REPORTED OCCURRENCE. THIS DEVICE PASSED ALL REQUIRED TESTING. EUROSETS CONFIRMED THAT 100% OF THE OXYGENATORS PRODUCED ARE TESTED TO DETECT EVENTUAL LEAKAGES USING A PRESSURE OF 150 KPA (KILOPASCALS) WHICH IS 1.5 TIMES THE MAXIMUM BLOOD PATHWAY PRESSURE INDICATED ON THE IFU (INSTRUCTIONS FOR USE). DEVICES THAT EXHIBIT LEAKS ARE DISCARDED PRIOR TO DISTRIBUTION. EUROSETS DETERMINED THAT THE ISSUE OCCURRED AFTER EUROSETS¿ MANUFACTURING AND TEST PHASES. AN ADDITIONAL INVESTIGATION OF OXYGENATOR LEAKING ISSUES HAS BEEN INITIATED BY ABBOTT AND SENT TO EUROSETS THROUGH A SUPPLIER CORRECTIVE ACTION REQUEST. THE PRODUCTION DOCUMENTATION FOR THE EUROSETS AMG PMP OXYGENATOR, LOT #9945208, WAS REVIEWED BY THE EXTERNAL MANUFACTURER (EUROSETS) AND SHOWED THAT ALL TESTS MADE IN THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. THE EUROSETS AMG MODULE PMP OXYGENATOR INSTRUCTIONS FOR USE (IFU), REV. 05, IS CURRENTLY AVAILABLE. UNDER THE LIST OF WARNINGS, THE IFU WARNS THAT DURING USE, A SPARE OXYGENATOR MUST ALWAYS BE AVAILABLE AND ALSO WARNS THAT THE DEVICE HAS TO BE CAREFULLY AND CONTINUOUSLY CHECKED BY QUALIFIED HEALTHCARE PROFESSIONALS THROUGHOUT THE PROCEDURE. ALSO, UNDER THE SECTION TITLED ¿SET UP¿, THE IFU WARNS TO ¿CARRY OUT A VISUAL INSPECTION AND CAREFULLY CHECK THE DEVICE BEFORE USE. TRANSPORT AND/OR STORAGE CONDITIONS OTHER THAN THOSE PRESCRIBED MAY HAVE CAUSED DAMAGE TO THE DEVICE.¿ NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION A1-A4: THERE WAS NO PATIENT INVOLVED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE OXYGENATORS WAS FOUND TO HAVE A LEAK DURING CIRCUIT PRIMING. THE OXYGENATOR WAS REMOVED AND REPLACED WITH ANOTHER OXYGENATOR WITH THE LOT NUMBER THAT DID NOT HAVE A VISIBLE LEAK AND WAS FINE BEING STORED IN THE PRIMED CIRCUIT.

    Description of Event or Problem · 0

    THE LEAK WAS NOTED WITHIN A MINUTE OF THE PRIMING SOLUTION FILLING THE CIRCUIT; IT WAS FLOWING AROUND 3L AT 2500 RPMS WHEN LEAK WAS NOTICED, AND NO PRESSURE READING ARE AVAILABLE WHEN PRIMING. THE LEAK WAS NOTICED TO HAVE BEEN COMING FROM THE UNDERSIDE OF THE POST OXYGENATOR PORT FROM THE PLASTIC ITSELF. NO PHOTOS OR VIDEOS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979718 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 9945208 08034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown