BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 9548296 · Received January 3, 2020

    Report

    Report Number
    2916596-2020-00014
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    Date of Event
    December 14, 2019
    Report Date
    July 21, 2020
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE PRODUCTION DOCUMENTATION FOR AMG PMP OXYGENATOR, LOT NUMBER 5830806, WAS REVIEWED BY THE EXTERNAL MANUFACTURER AND SHOWED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. THE REPORT OF A BLOOD LEAK COULD NOT BE CONFIRMED AND NO DEVICE-RELATED ISSUES WERE DISCOVERED DURING THE EVALUATION OF THE RETURNED OXYGENATOR. THE EUROSETS AMG PMP OXYGENATOR, LOT NUMBER 5830806, WAS RETURNED TO ABBOTT AND AN INITIAL VISUAL INSPECTION WAS PERFORMED. VISUAL INSPECTION OF THE OXYGENATOR SHOWED NO OBVIOUS CRACKS OR DAMAGE TO THE EXTERNAL HOUSING OR PORTS. THE OXYGENATOR WAS THEN FORWARDED TO THE EXTERNAL MANUFACTURER FOR TECHNICAL ANALYSIS. UPON RECEIPT AT EUROSETS, THE OXYGENATOR WAS CLEANED AND DRIED BEFORE PROCEEDING WITH THE FUNCTIONAL TEST. THE TEST CIRCUIT WAS FILLED WITH PHYSIOLOGICAL WATER AND AN INITIAL FLOW OF 4 LPM WAS ESTABLISHED. AFTER 30 MINUTES OF OPERATION, NO LEAKS FROM THE OXYGENATOR WERE IDENTIFIED. THE FLOW WAS THEN INCREASED TO THE MAXIMUM RECOMMENDED FLOW OF 7 LPM AS INDICATED IN THE AMG MODULE PMP IFU, AND A COUNTER PRESSURE AT THE BLOOD OUTLET OF THE OXYGENATOR WAS APPLIED BY PARTIALLY CLAMPING THE CONNECTOR AT THE BLOOD OUTLET OF THE OXYGENATOR. AFTER 2 HOURS OF OPERATION, NO LEAKS FROM THE OXYGENATOR WERE IDENTIFIED. FUNCTIONAL TESTING OF THE OXYGENATOR REVEALED NO SOURCE OF LEAKAGE AND THE MANUFACTURER DETERMINED THAT THE DEVICE WAS COMPLIANT WITH PRODUCT SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATIENT WENT ON ECMO THE NURSE NOTED A GROWING SPOT OF BLOOD ON THE FLOOR UNDER THE OXYGENATOR. THE NURSE CHECKED THE CAPS, AND NOTHING WAS LOOSE. THEY COULD SEE AN OBVIOUS DRIP BUT NO CLEAR SOURCE OF THE LEAK. THEY OPTED TO EXCHANGE IT. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5932 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. 100170048

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R