BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 13711593 · Received March 9, 2022

    Report

    Report Number
    2916596-2022-01366
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    December 25, 2021
    Report Date
    May 18, 2022
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    PMA / PMN Number
    K141492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE RETURNED EUROSETS AMG PMP OXYGENATOR, LOT NUMBER: 6920908, CONFIRMED A BROKEN FIBER THAT WOULD HAVE RESULTED IN THE REPORTED LEAK DURING PRIMING. THE DEVICE WAS RETURNED FOR TO THE MANUFACTURER FOR FURTHER ANALYSIS, WHICH CONFIRMED THAT THE LEAK REPORTED DURING THE PRIMING PHASE CAN BE RELATED TO A FIBER RUPTURE OCCURRED AFTER EUROSETS MANUFACTURING AND TEST PHASES. A SPECIFIC ROOT CAUSE FOR THE FIBER BREAKAGE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE EUROSETS AMG PMP OXYGENATOR WAS RETURNED TO ABBOTT, AND VISUAL INSPECTION OF THE OXYGENATOR REVEALED A BROKEN FIBER IN THE BLOOD OUTLET PORT OF THE OXYGENATOR. INSPECTION OF THE REMAINING PARTS OF THE OXYGENATOR REVEALED NO OBVIOUS DAMAGE OR ANOMALIES TO THE EXTERNAL HOUSING, PORTS, OR FIBERS. NO BLOOD WAS OBSERVED WITHIN THE DEVICE WHICH COINCIDES WITH THE REPORTED EVENT OCCURRING DURING THE DEVICE PRIMING PROCESS, PRIOR TO PATIENT USE. THE AMG PMP OXYGENATOR WAS FORWARDED TO THE EXTERNAL MANUFACTURER FOR TECHNICAL ANALYSIS. THE RESERVOIR WAS FILLED WITH 500 ML OF PHYSIOLOGICAL WATER; THE OXYGENATOR MODULE WAS FILLED FROM THE RESERVOIR USING A PERISTALTIC PUMP (Q = 6 L/MIN) AND REMAINED IN LOOP FOR 10 MINUTES. A SLOW DRIPPING IN THE LOWER PART OF THE OXYGENATOR, IN FRONT OF THE ARTERIAL BLOOD OUT WAS OBSERVED. THE LEAK REPORTED DURING THE PRIMING PHASE CAN BE RELATED TO A FIBER RUPTURE OCCURRED AFTER EUROSETS MANUFACTURING AND TEST PHASES. EUROSETS REVIEWED THE PRODUCTION DOCUMENTATION FOR THE OXYGENATOR LOT AND CONFIRMED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. EUROSETS APPLIES THE PRODUCTION PROCESS TESTS TO ONE HUNDRED PERCENT OF THEIR MANUFACTURED OXYGENATORS. THE EUROSETS AMG PMP INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. UNDER THE LIST OF WARNINGS, THE IFU WARNS THAT DURING THE EXTRACORPOREAL CIRCULATION (ECC) A BACKUP OXYGENATOR IS NECESSARY AND ALSO WARNS THAT THE EXTRACORPOREAL CIRCULATION HAS TO BE CAREFULLY AND CONTINUOUSLY CHECKED. ALSO UNDER THE LIST OF WARNINGS, THE IFU WARNS THAT ¿BEFORE USING THE PRODUCT IT IS ADVISABLE TO CAREFULLY INSPECT IT. SHIPPING AND HANDLING COULD CAUSE STRUCTURAL AND FUNCTIONAL DAMAGE TO THE DEVICE.¿ UNDER THE SECTION TITLED, ¿PRIMING AND RECIRCULATION PROCEDURE¿, THE IFU PROVIDES INSTRUCTIONS ON HOW TO PRIME THE OXYGENATOR FOR USE INCLUDING VERIFYING THE INTEGRITY OF THE HEAT EXCHANGER AND PAYING PARTICULAR ATTENTION TO POSSIBLE WATER LEAKS. THIS SECTION FURTHER WARNS THAT THE ¿PRESSURE LEVEL INSIDE THE BLOOD COMPARTMENT OF THE OXYGENATING MODULE SHALL NOT EXCEED 100 KPA (1 BAR / 14 PSI)¿ AND THAT THE ¿BLOOD SIDE COMPARTMENT PRESSURE MUST BE HIGHER THAN THE GAS SIDE COMPARTMENT PRESSURE¿. ADDITIONALLY, THIS SECTION STATES THAT THE OXYGENATOR SHOULD BE PRIMED BY GRAVITY. THE IFU PROVIDES FURTHER INSTRUCTIONS ON HOW TO OPEN THE ARTERIAL LINE, HOW TO PURGE THE AIR CONTAINED IN THE CIRCUIT, HOW TO CLOSE THE PURGING LINE, AND HOW TO CLOSE THE VENOUS AND ARTERIAL LINES IN THIS SECTION. UNDER THE SECTION TITLED ¿OXYGENATOR REPLACEMENT¿, THIS DOCUMENT STATES THAT A SPARE OXYGENATOR MUST ALWAYS BE AVAILABLE DURING PERFUSION. AFTER 6 HOURS OF USE WITH BLOOD OR IF PARTICULAR SITUATIONS OCCUR, WHICH MAY LEAD THE PERSON RESPONSIBLE FOR PERFUSION TO DETERMINE THE SAFETY OF THE PATIENT MAY BE COMPROMISED (INSUFFICIENT OXYGENATOR PERFORMANCE, LEAKS, ABNORMAL BLOOD PARAMETERS, ETC.), FOLLOW THE PROCEDURE OUTLINED IN THE IFU FOR OXYGENATOR REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CIRCUIT SET UP AND PRIMING WE NOTICED THERE WAS A LEAK FROM THE AMALGAMATION OF MARGINAL GAINS (AMG) OXYGENATOR. THE OXYGENATOR WAS SWAPPED FOR ANOTHER AMG AND THERE WASN'T ANY ISSUES AFTER THE SWAP. THE OXYGENATOR WAS SET ASIDE.

    Description of Event or Problem · 0

    CORRECTION: IT WAS REPORTED THAT DURING CIRCUIT SET UP AND PRIMING THERE WAS A LEAK FROM THE ADVANCED MEMBRANE GAS EXCHANGE (AMG) OXYGENATOR. THE OXYGENATOR WAS SWAPPED FOR ANOTHER OXYGENATOR AND THERE WEREN'T ANY ISSUES AFTER THE SWAP. THE OXYGENATOR WAS SET ASIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170893 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 6920908

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown