BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUROSET OXYGENATOR

    MDR report key: 9331159 · Received November 15, 2019

    Report

    Report Number
    2916596-2019-05172
    Event Type
    Injury
    Date Received
    November 15, 2019
    Date of Event
    October 19, 2019
    Report Date
    June 30, 2020
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    UDI-DI
    08034013782020
    PMA / PMN Number
    K141492
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A3: CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: THE EVALUATION OF THE RETURNED OXYGENATOR REVEALED NO DEVICE-RELATED ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT OF POOR GAS EXCHANGE AND THE DEVICE CLOTTING OFF. THE EUROSETS AMG PMP OXYGENATOR, LOT NUMBER 5830806, WAS RETURNED TO ABBOTT AND AN INITIAL VISUAL INSPECTION WAS PERFORMED. THE OXYGENATOR WAS RETURNED FILLED WITH BLOOD. 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 WASHED WITH A SALINE SOLUTION AND DRIED BEFORE PROCEEDING WITH THE FUNCTIONAL TEST. THE FUNCTIONAL TEST WAS PERFORMED USING BOVINE BLOOD WITH PARAMETERS COMPLIANT TO INTERNATIONAL STANDARDS. THE O2 AND CO2 GAS TRANSFER PERFORMANCE AND THE PRESSURE DROPS ACROSS THE OXYGENATOR MEASURED DURING THE TEST WERE IN LINE WITH THE TECHNICAL SPECIFICATIONS. THE MANUFACTURER DETERMINED THAT THE DEVICE WAS COMPLIANT WITH THE PRODUCT SPECIFICATIONS AND THE REPORTED EVENT COULD NOT BE CORRELATED TO A DEVICE-RELATED ISSUE. HOWEVER, THE REPORTED INFORMATION INDICATED THAT THERE WAS DIFFICULTY GETTING THE PATIENT THERAPEUTIC ON BIVALIRUDIN AND THE PTT DURING THE HOSPITAL PROCEDURE DID NOT EXCEED 40 SECONDS. BASED ON INTERNATIONAL GUIDELINES, WHICH WERE NOTED TO ALIGN WITH THE HOSPITAL¿S BIVALIRUDIN PROTOCOL, THE MANUFACTURER SUGGESTS MAINTAINING A PTT RANGE OF AROUND 61-75 SECONDS. 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 EUROSETS AMG PMP INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. THE SECTION TITLED "INTENDED USE" EXPLAINS THAT THE AMG MODULE PMP NO T.P. STERILE IS INTENDED FOR USE IN ADULT SURGICAL PROCEDURES REQUIRING EXTRACORPOREAL GAS EXCHANGE SUPPORT AND BLOOD TEMPERATURE CONTROL FOR PERIODS OF UP TO 6 HOURS. THE AMG MODULE PMP NO T.P. STERILE IS INTENDED TO BE USED IN AN EXTRACORPOREAL PERFUSION CIRCUIT TO OXYGENATE AND REMOVE CARBON DIOXIDE FROM THE BLOOD AND TO COOL OR WARM THE BLOOD DURING ROUTINE CARDIOPULMONARY BYPASS PROCEDURES UP TO 6 HOURS IN DURATION. CONTACT WITH BLOOD FOR A LONGER PERIOD OF TIME IS UNADVISABLE. UNDER THE LIST OF WARNINGS, THE IFU WARNS THAT DURING THE EXTRACORPOREAL CIRCULATION (ECC) A BACKUP OXYGENATOR IS NECESSARY. UNDER THE LIST OF PRECAUTIONS, THE IFU CAUTIONS THAT A STRICT ANTICOAGULATION PROTOCOL SHOULD BE FOLLOWED AND ANTICOAGULATION SHOULD BE ROUTINELY MONITORED DURING ALL PROCEDURES. THE BENEFIT OF EXTRACORPOREAL SUPPORT MUST BE WEIGHED AGAINST THE RISK OF SYSTEMIC ANTICOAGULATION AND MUST BE ASSESSED BY THE PRESCRIBING PHYSICIAN. ADEQUATE HEPARINIZATION MUST BE MAINTAINED BEFORE AND DURING BYPASS. THE "PRIMING AND RECIRCULATION PROCEDURE" SECTION WARNS TO CHECK THE CORRECT DOSAGE OF ANTICOAGULANT IN THE SYSTEM BEFORE STARTING THE BYPASS. THE "BYPASS START" SECTION STATES TO CHECK THAT ANTICOAGULATION LEVEL (ACT) IS APPROPRIATE BEFORE STARTING THE PROCEDURE. THE "DURING BYPASS" WARNS THAT THE ACT (ACTIVATED COAGULATION TIME) MUST ALWAYS BE LONGER THAN OR EQUAL TO 480 SECONDS IN ORDER TO ENSURE ADEQUATE ANTICOAGULATION OF THE EXTRACORPOREAL CIRCUIT. 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 THAT 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 · 1

    FROM THE PRELIMINARY ANALYSIS BY MANUFACTURER, THE ISSUE APPEARS TO BE RELATED TO PATIENT CONDITION AND ANTICOAGULATION. SINCE THIS IS AN UNIQUE CASE ALL OTHER MANIPULATIONS WENT VERY WELL. THE PRODUCT HAS BEEN RETURNED IS CURRENTLY UNDER INVESTIGATION AT THE MANUFACTURER. 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 THERE WAS DIFFICULTY GETTING THE PATIENT THERAPEUTIC ON BIVALIRUDIN AND THE OXYGENATOR CLOTTED OFF. THE OXYGENATOR WAS SUBSEQUENTLY EXCHANGED THE PATIENT IS ONGOING ON ANOTHER MANUFACTURER'S DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122013 EUROSET OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 5830806 08034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other