BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR WITH INTEGRATED HEAT EXCHANGER

    MDR report key: 8367077 · Received February 25, 2019

    Report

    Report Number
    8010762-2019-00045
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    February 15, 2019
    Report Date
    July 29, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K100278
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). DEVICE REQUESTED BUT NOT RETURNED TO DATE. REFERENCE EXEMPTION # E2018002.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: MASSIVE HEMOLYSIS IMMEDIATELY AFTER START OF THERAPY. PLASMA FREE HEMOGLOBIN WAS ONLY MEASURED AT THE START OF ECMO. ECMO WAS INITIATED AT 0846, AND THE FIRST PLASMA FREE HEMOGLOBIN WAS DRAWN AT 1000 WITH A RESULT OF 1340MG/DL. THE NEXT PLASMA FREE WAS DRAWN AT 1410 WITH A RESULT OF 2690MG/DL. THE LAST PLASMA FREE DRAWN BEFORE CIRCUIT CHANGE WAS AT 1555 AND WAS 2800MG/DL. A PLASMA FREE WAS DRAWN FROM THE NEW CIRCUIT PRIOR TO INITIATION AND WAS <30. FOLLOWING CIRCUIT CHANGE, THE PLAMSA FREE DROPPED TO 1650, 1220, 840, 600, 430, 350, 270, OVER THE NEXT 24 HOURS RESPECTIVELY. THEY CHANGED OUT THE CIRCUIT. MEDTRONIC TUBING SET, CORTIVA COATED WAS USED. OXYGENATOR WAS FLUSHED AFTER REMOVAL WITH SALINE AND THERE WAS NO VISUAL EVIDENCE OF CLOT OR FIBRIN. NO HARM TO THE PATIENT WAS REPORTED. INTERNAL REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 1

    THE RETURNED HMOD 3000 WAS INVESTIGATED IN THE LABORATORY OF THE MANUFACTURER ON 2019-05-15. A VISUAL INSPECTION WAS PERFORMED AND A NO ABNORMALITIES ON THE OXY ARE DETECTED. THE AFFECTED OXYGENATOR WAS USED WITH A PEDIMAG PUMP TOGETHER WITH A TUBE SET FROM THE MANUFACTURER MEDTRONIC. THE PUMP AND THE TUBING SET WAS NOT RETURNED THEREFORE READJUSTMENT TEST WITH ALL USED COMPONENT IS NOT POSSIBLE. THUS THE FAILURE COULD NOT BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION AT THIS TIME THE MOST PROBABLE CAUSE OF THE REPORTED INCIDENT IS UNKNOWN. ACCORDING TO THE THERAPY APPLICATION MANAGER: "IT CAN NOT BE CLARIFIED PROPERLY, WHICH WAS RESPONSIBLE FOR THE BLOOD TRAUMATIZATION. REASON: WHEN THE ERYTHROCYTE CONCENTRATE HAS BEEN EXAMINED FOR HAEMOLYSIS (FREE PLASMA HEMOGLOBIN) AND NO SIGNIFICANT HAEMOLYSIS HAS BEEN MEASURED, THE LIKELIHOOD THAT THE COMPONENTS OF THE ECMO SYSTEM ARE TRIGGERS INCREASES. FURTHER INVESTIGATION MEASURES THAT MAY PROVIDE INFORMATION ON THE CAUSE OF BLOOD TRAUMATIZATION IN THE OXYGENATOR, ARE DIFFICULT TO CARRY OUT."

    Description of Event or Problem · 1

    INTERNAL REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161616 OXYGENATOR WITH INTEGRATED HEAT EXCHANGER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG BEQ-HMOD30000-USA#Q 70124689

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention