BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 20032883 · Received August 22, 2024

    Report

    Report Number
    3003752502-2024-00027
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    January 30, 2024
    Report Date
    January 7, 2025
    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
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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

    SECTIONS B1 AND B2: CORRECTED. SECTION H1: TYPE OF REPORTABLE EVENT. SECTION H6: HEALTH EFFECT - CLINICAL CODE AND HEALTH EFFECT - IMPACT CODE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF OXYGENATOR CLOTS AND DECREASED GAS EXCHANGE WAS UNABLE TO BE CONFIRMED AS NO IMAGES OR PRODUCT WAS AVAILABLE FOR EVALUATION. THE OXYGENATOR MANUFACTURER (EUROSETS) DETERMINED THAT THE ROOT CAUSE OF THE PROBLEM COULD NOT BE DETERMINED WITH ONLY THE AVAILABLE INFORMATION AND WITHOUT THE DEVICE FOR TECHNICAL INVESTIGATION. THE EUROSETS AMG PMP OXYGENATOR, LOT #9292008, WOULD REPORTEDLY NOT BE RETURNED FOR EVALUATION. THE PRODUCTION DOCUMENTATION FOR THE EUROSETS AMG PMP OXYGENATOR, LOT #9292008, WAS REVIEWED BY THE EXTERNAL MANUFACTURER (EUROSETS) AND SHOWED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. EUROSETS DETERMINED THAT THE ROOT CAUSE OF THE PROBLEM COULD NOT BE DETERMINED WITH ONLY THE AVAILABLE INFORMATION AND WITHOUT THE DEVICE FOR TECHNICAL INVESTIGATION. THE EUROSETS AMG PMP INSTRUCTIONS FOR USE (IFU), REV. 05, IS CURRENTLY AVAILABLE. UNDER ¿RISKS AND SIDE EFFECTS,¿ THE IFU LISTS POSSIBLE RISKS AND SIDE EFFECTS, INCLUDING THROMBOSIS/OXYGENATOR CLOTTING AND INSUFFICIENT GAS EXCHANGE (INCLUDING INSUFFICIENT CO2 REMOVAL). THESE ARE POTENTIAL SIDE EFFECTS OF ALL EXTRACORPOREAL BLOOD CIRCULATION SYSTEMS. UNDER THE LIST OF WARNINGS, THE IFU WARNS THAT DURING USE, A SPARE OXYGENATOR MUST ALWAYS BE AVAILABLE. THE IFU ALSO WARNS THAT THE PATIENT AND DEVICE MUST BE CAREFULLY AND CONTINUOUSLY CHECKED BY QUALIFIED HEALTHCARE PROFESSIONALS THROUGHOUT THE PROCEDURE. THE IFU ALSO RECOMMENDS MONITORING BLOOD COAGULATION PARAMETERS DURING BYPASS. ABSENCE OF ADEQUATE ANTICOAGULATION MAY RESULT IN CLOTTING WITHIN THE SYSTEM AND CONSEQUENTLY OCCLUSION OF THE CIRCUIT. UNDER THE SECTION TITLED, ¿BYPASS START¿, THE IFU CONTAINS A SUBSECTION ON BLOOD GAS MONITORING AND EXPLAINS HOW TO ADJUST THE RELEVANT PARAMETERS BASED ON THE PATIENT¿S BLOOD GAS VALUES. 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 THE OXYGENATOR WAS EXCHANGED ON (B)(6) 2024 AT 16:30 WHILE IN THE OPERATING ROOM DURING IMPELLA INSERTION. THERE WERE CONCERNS ABOUT CLOTS ON THE OXYGENATOR AND DECREASED CO2 EXCHANGE.

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT THE PATIENT¿S PARTIAL THROMBOPLASTIN TIME (PTT) WAS 38.8. PRIOR TO THE OXYGENATOR EXCHANGE, FLOW WAS APPROXIMATELY 4 LITERS PER MINUTE (LPM) AT PUMP SPEED OF 5450 REVOLUTIONS PER MINUTE (RPM). AFTER THE OXYGENATOR EXCHANGE, FLOW WAS APPROXIMATELY 4 LPM AT PUMP SPEED OF 4750 RPM. THE REPORTED BLOOD GAS VALUES INDICATED THAT THE PARTIAL PRESSURE OF CO2 (PCO2) WAS REDUCED ACROSS THE OXYGENATOR FROM 59 TO 52 MILLIMETERS OF MERCURY (MMHG) WITH 100% FRACTION OF DELIVERED OXYGEN (FDO2) AT 4 LPM. AFTER THE OXYGENATOR EXCHANGE, THE PCO2 WAS ABLE TO BE REDUCED FROM 73 TO 67 MMHG WITH 100% FDO2 AT 3 LPM. POST-OXYGENATOR BLOOD OXYGEN SATURATION REMAINED AT 100%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953307 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 009292008 08034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Life Threatening| R