BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 20249585 · Received September 18, 2024

    Report

    Report Number
    3003752502-2024-00028
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    August 27, 2024
    Report Date
    March 28, 2025
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    UDI-DI
    08034013782020
    PMA / PMN Number
    K141492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9: CORRECTED SECTION H6 - MEDICAL DEVICE PROBLEM CODE: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED SOUND WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION; HOWEVER, EUROSETS' INVESTIGATION OF THE RETURNED DEVICE DETERMINED THAT THE DEVICE FUNCTIONED AS INTENDED. THE EUROSETS ADVANCED MEMBRANE GAS EXCHANGE (AMG) POLYMETHYLPENTENE (PMP) OXYGENATOR, LOT NUMBER 9945208, WAS RETURNED AND AN INITIAL VISUAL INSPECTION WAS PERFORMED. VISUAL INSPECTION OF THE OXYGENATOR REVEALED NO OBVIOUS DAMAGE. THE AMG PMP OXYGENATOR WAS FORWARDED TO THE EXTERNAL MANUFACTURER, EUROSETS, FOR TECHNICAL ANALYSIS. EUROSETS¿ TECHNICAL INVESTIGATION CONFIRMED THAT THE CLAIMED DEVICE WAS COMPLIANT WITH THE TECHNICAL SPECIFICATION AND FOR THIS REASON EUROSETS WAS NOT ABLE TO CONFIRM THE COMPLAINT BY THE CUSTOMER. THE PRODUCTION DOCUMENTATION FOR AMG PMP OXYGENATOR, LOT NUMBER 9945208, WAS REVIEWED BY THE EXTERNAL MANUFACTURER (EUROSETS) AND SHOWED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. THE EUROSETS AMG (ADVANCED MEMBRANE GAS EXCHANGE) PMP (POLYMETHYLPENTENE) INSTRUCTIONS FOR USE (IFU), REV. 05, IS CURRENTLY AVAILABLE. THE SECTION ENTITLED ¿INTENDED USE¿ STATES THAT THE AMG PMP OXYGENATOR IS INTENDED TO BE USED IN AN EXTRACORPOREAL PERFUSION CIRCUIT TO OXYGENATE AND REMOVE CARBON DIOXIDE FROM THE BLOOD TO COOL OR POSSIBLY WARM THE BLOOD DURING ROUTINE CARDIOPULMONARY BYPASS PROCEDURES FOR UP TO 6 HOURS IN DURATION. 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.¿ THE SECTION ENTITLED ¿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.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    B5 NARRATIVE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OXYGENATOR WAS PRE-PRIMED FOR THE BACKUP CIRCUIT. THE DAILY CHECK WAS MADE TO THE CIRCUIT AND IT WAS NOTED THAT UPON INCREASING THE FLOW A WHISTLING SOUND WAS HEARD. THE FASTER THE FLOW THE LOUDER THE WHISTLING SOUND WAS. THE OXYGENATOR WAS CHECKED FOR AIR AND THE FLOW WAS LEFT RUNNING TO SEE IF IT STOPPED. THE SOUND CONTINUED SO THE OXYGENATOR WAS REPLACED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE WHISTLING NOISE WAS NOTED ABOUT 8 HOURS AFTER PRIMING. THE WHISTLE WAS THOUGHT TO BE DUE TO "TIGHT FIBERS" IN THE OXYGENATOR. THE OXYGENATOR WAS PRIMED WITH NORMOSOL. IT STARTED TO WHISTLE AROUND 1700 RPMS AND WAS QUITE LOUD AT 2400 RPMS. IT WAS LIKELY AT AROUND 3.5 LPM OF FLOW. THE SWEEP WAS NOT FLOWING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301906 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