BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLUNG KIT 230

    MDR report key: 12063579 · Received June 24, 2021

    Report

    Report Number
    3012172416-2021-00023
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 26, 2021
    Report Date
    July 22, 2021
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    PMA / PMN Number
    K191407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A2, A4.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONNECTOR AT THE ARTERIAL VENT PORT P3 (POS. 3) WAS LEAKING BLOOD BETWEEN THE TUBING AND THE RED THREE-WAY STOPCOCK (LUER LOCK CONNECTION). THIS OCCURRED THREE DAYS INTO A PATIENT¿S EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY. THE PRODUCT WAS NOT EXCHANGED, AND THE SYSTEM CONTINUED TO RUN. THERE WERE NO FRACTURES THAT COULD BE CLEARLY SEEN ON THE VENTING LINE AND THE VENTING LINE DID NOT DISCONNECT. HOWEVER, A CRACK IN THE LUER LOCK NEGATIVE ADAPTER WAS DESCRIBED. THE VENTING LINE WAS CLAMPED AND THERE WERE NO FURTHER ISSUES. THE XLUNG KIT WAS INSPECTED FOR DAMAGE PRIOR TO USE AND THE CONNECTIONS WERE CHECKED; NO DAMAGE WAS FOUND. THERE WERE NO CONSOLE ALARMS ASSOCIATED WITH THE EVENT, AND NO ALARMS WERE EXPECTED. THE EVENT RESULTED IN APPROXIMATELY 200 ML OF BLOOD LOSS, OR LESS. THERE WAS NO PATIENT INJURY, ADVERSE EFFECTS EXPERIENCED, OR MEDICAL INTERVENTION REQUIRED DUE TO THE REPORTED EVENT. THE PATIENT COMPLETED THEIR TREATMENT USING THE SAME DEVICE. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED, AND NO PHOTOS WERE AVAILABLE FOR REVIEW.

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION: THE PRODUCT SAMPLE WAS NOT RETURNED TO THE MANUFACTURER, AND THEREFORE A PHYSICAL EVALUATION COULD NOT BE PERFORMED. NO ANOMALIES OR DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING RECORDS. THE DESCRIPTION INDICATES A DEFECT IN THE CONNECTIONS OF THE ARTERIAL VENTING LINE. ACCORDING TO THE DESCRIPTION, THE DEFECT WAS LOCATED BETWEEN THE CONNECTION OF THE LUER LOCK NEGATIVE ADAPTER AND THE THREE-WAY STOPCOCK. A CRACK IN THE LUER LOCK NEGATIVE ADAPTER WAS DESCRIBED. BASED ON THE AVAILABLE INFORMATION, IT IS LIKELY THAT THE LEAK WAS CAUSED BY A DEFECT IN THE LUER LOCK NEGATIVE ADAPTER. HOWEVER, THE DEFECT COULD NOT BE VERIFIED BY AN EXAMINATION OF THE PRODUCT, AND PHOTOS WERE NOT PROVIDED FOR REVIEW. AS THE DAMAGED COMPONENT IS A PURCHASED PART, THE MANUFACTURER HAS BEEN NOTIFIED OF THE DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTOR AT THE ARTERIAL VENT PORT P3 (POS. 3) WAS LEAKING BLOOD BETWEEN THE TUBING AND THE RED THREE-WAY STOPCOCK (LUER LOCK CONNECTION). THIS OCCURRED THREE DAYS INTO A PATIENT¿S EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY. THE PRODUCT WAS NOT EXCHANGED, AND THE SYSTEM CONTINUED TO RUN. THERE WERE NO FRACTURES THAT COULD BE CLEARLY SEEN ON THE VENTING LINE AND THE VENTING LINE DID NOT DISCONNECT. HOWEVER, A CRACK IN THE LUER LOCK NEGATIVE ADAPTER WAS DESCRIBED. THE VENTING LINE WAS CLAMPED AND THERE WERE NO FURTHER ISSUES. THE XLUNG KIT WAS INSPECTED FOR DAMAGE PRIOR TO USE AND THE CONNECTIONS WERE CHECKED; NO DAMAGE WAS FOUND. THERE WERE NO CONSOLE ALARMS ASSOCIATED WITH THE EVENT, AND NO ALARMS WERE EXPECTED. THE EVENT RESULTED IN APPROXIMATELY 200 ML OF BLOOD LOSS, OR LESS. THERE WAS NO PATIENT INJURY, ADVERSE EFFECTS EXPERIENCED, OR MEDICAL INTERVENTION REQUIRED DUE TO THE REPORTED EVENT. THE PATIENT COMPLETED THEIR TREATMENT USING THE SAME DEVICE. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED, AND NO PHOTOS WERE AVAILABLE FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953143 XLUNG KIT 230 QJZ QJZ XENIOS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR NOVALUNG CONSOLE| NOVALUNG CONSOLE