BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLUNG KIT 230

    MDR report key: 11757850 · Received April 30, 2021

    Report

    Report Number
    3012172416-2021-00013
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 30, 2021
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    PMA / PMN Number
    K191407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION: THE PRODUCT SAMPLE WAS NOT RETURNED TO THE MANUFACTURER, AND THEREFORE A PHYSICAL EVALUATION COULD NOT BE PERFORMED. HOWEVER, A PHOTOGRAPH SHOWING THE DEFECT WAS PROVIDED FOR REVIEW. THE IMAGE REVEALED THAT A DEFECT WAS PRESENT ON THE LUER LOCK NEGATIVE ADAPTER, AT THE ARTERIAL VENTING LINE. THE IDENTIFIED DEFECT WOULD HAVE LED TO THE DESCRIBED LEAKAGE. NO ANOMALIES OR DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING RECORDS. SINCE THE DAMAGED COMPONENT IS A PURCHASED PART, THE MANUFACTURER HAS BEEN NOTIFIED TO FURTHER INVESTIGATE THIS DEFECT. BASED ON THE AVAILABLE INFORMATION, IT IS LIKELY THAT THE LEAKAGE WAS CAUSED BY A DEFECT IN THE LUER LOCK NEGATIVE ADAPTER, AND THE COMPLAINT IS JUSTIFIED.

    Description of Event or Problem · 1

    A PATIENT WHO WAS PLACED ON VENO-VENOUS (VV) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY EXPERIENCED BLOOD LOSS DUE TO A HAIRLINE CRACK AT THE RECIRCULATION PORT (RED) TUBE. THE EVENT OCCURRED ON DAY 2 OF ECMO THERAPY. THE DEVICE WAS INSPECTED FOR DAMAGE PRIOR TO USE, AND NO DAMAGE WAS FOUND. THERE WAS NO LEAKAGE NOTED DURING THE PRIMING PHASE. THERE WERE NO ALARMS FROM THE CONSOLE ASSOCIATED WITH THE REPORTED EVENT. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS 250 ML. AFTER THE BLOOD LEAK WAS IDENTIFIED, THE TUBING WAS CLAMPED, AND THE SYSTEM WAS CHANGED. THERE WAS NO INFORMATION ABOUT THE PATIENT¿S ULTIMATE OUTCOME. HOWEVER, IT WAS CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION REQUIRED DUE TO THE REPORTED EVENT. DATA RELATED TO THE PERFUSION PROTOCOL WAS NOT PROVIDED AND THE LOGFILE OF THE CONSOLE WAS REPORTEDLY UNAVAILABLE. A PHOTO OF THE AFFECTED COMPONENT WAS PROVIDED FOR REVIEW. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649947 XLUNG KIT 230 QJZ QJZ XENIOS AG 8013886

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR