BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 18301467 · Received December 11, 2023

    Report

    Report Number
    3003752502-2023-02408
    Event Type
    Malfunction
    Date Received
    December 11, 2023
    Date of Event
    November 12, 2023
    Report Date
    June 24, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4 - CATALOG NUMBER: CORRECTED. SECTION D4 - LOT NUMBER: CORRECTED. SECTION D4 - PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE RETURNED OXYGENATOR BY THE MANUFACTURER (EUROSETS) CONFIRMED AN OXYGENATOR LEAK DUE TO AN IMPROPERLY SECURED CABLE TIE ON THE PURGE LINE. THE EUROSETS AMG (ADVANCED MEMBRANE GAS EXCHANGE) PMP (POLYMETHYLPENTENE) OXYGENATOR, LOT NUMBER 7896808, WAS RETURNED TO THE ABBOTT FACILITY IN (B)(4), WHERE AN INITIAL VISUAL INSPECTION WAS PERFORMED. VISUAL INSPECTION OF THE OXYGENATOR REVEALED NO OBVIOUS DAMAGE TO THE EXTERNAL HOUSING, PORTS, OR FIBERS. THERE WERE NO ABNORMALITIES NOTED. THE OXYGENATOR WAS FORWARDED TO THE EXTERNAL MANUFACTURER, EUROSETS, FOR TECHNICAL ANALYSIS. THE OXYGENATOR WAS SET UP IN A CIRCUIT WITH A 500-MILLILITER RESERVOIR OF PHYSIOLOGICAL WATER AND PERISTALTIC PUMP. THE OXYGENATOR WAS FILLED WITH PHYSIOLOGICAL WATER VIA THE PERISTALTIC PUMP, AND THE WATER WAS CIRCULATED THROUGH THE OXYGENATOR AT A FLOW OF 6 LITERS PER MINUTE (LPM) FOR 10 MINUTES. A SLOW DRIPPING WAS NOTICED IN THE UPPER PART OF THE OXYGENATOR DUE TO AN IMPROPERLY SECURED CABLE TIE ON THE PURGE LINE. THE PRODUCTION DOCUMENTATION FOR OXYGENATOR, LOT NUMBER 7896808, WAS REVIEWED BY THE EXTERNAL MANUFACTURER (EUROSETS) AND SHOWED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. EUROSETS CALCULATED THE OCCURRENCE RATE FOR THE REPORTED ISSUE AND DETERMINED THAT THIS IS AN ISOLATED CASE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. HOWEVER, IT WAS REQUIRED TO PLAN A TRAINING TO THE OPERATORS IN ORDER TO AVOID THE RE-OCCURRENCE OF THIS ISSUE. THE EUROSETS AMG PMP 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. 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.

    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 DURING BACK-UP CIRCUIT CHECKS, ONE OF THE OXYGENATORS BEING PRIMED TO SERVE AS A BACKUP CIRCUIT HAD A LEAK. THE PRESSURE TUBING WAS CHANGED OUT FIRST, BUT THE LEAK DID NOT STOP. THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) COORDINATOR MADE THE CONCLUSION THAT THE LEAK WAS COMING FROM THE BOTTOM OF THE OXYGENATOR WHERE THE BLUE AND THE ORANGE PLASTIC MEET RIGHT ABOVE THE VENOUS PRESSURE LINE CONNECTION. IT WAS NOTED THAT THE OXYGENATOR WAS CHANGED IN STERILE CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136642 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 7896808 08034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown