BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLUNG KIT 230

    MDR report key: 11784366 · Received May 6, 2021

    Report

    Report Number
    3012172416-2021-00015
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 3, 2021
    Report Date
    June 9, 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

    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 REPORTED COMPLAINT DESCRIPTION INDICATES A DEFECT WAS PRESENT IN THE CONNECTIONS OF THE ARTERIAL AND VENOUS VENT LINE. AFTER FURTHER CONSULTATION, THE LEAKS COULD BE ASSIGNED TO THE CONNECTION OF THE LUER LOCK NEGATIVE ADAPTER AND THE THREE-WAY STOPCOCK. BASED ON THE INFORMATION AVAILABLE, IT IS LIKELY THAT THE LEAK WAS CAUSED BY A DEFECT IN THE LUER LOCK NEGATIVE ADAPTER. SINCE THE DAMAGED COMPONENT IS A PURCHASED PART, THE MANUFACTURER HAS BEEN NOTIFIED TO FURTHER INVESTIGATE THIS DEFECT. THE COMPLAINT IS CLASSIFIED AS JUSTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO WAS PLACED ON VENO-VENOUS (VV) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY EXPERIENCED BLOOD LOSS DUE TO A HAIRLINE FRACTURE FOUND IN THE ARTERIAL VENTING LINE OF THE XLUNG KIT A FEW HOURS AFTER TREATMENT INITIATION. THE DEVICE WAS INSPECTED FOR DAMAGE PRIOR TO USE AND NO DAMAGE WAS FOUND. THERE WAS NO LEAKING NOTICED DURING THE PRIMING PHASE. THERE WERE NO ALARMS FROM THE CONSOLE ASSOCIATED WITH THE REPORTED EVENT. THERE WAS NO REPORT OF THE XLUNG KIT BEING REPLACED. TO RESOLVE THE REPORTED ISSUE, THE VENTING LINE WAS CLAMPED, AND TREATMENT THEN CONTINUED. A SECOND HAIRLINE FRACTURE WHICH RESULTED IN ADDITIONAL BLOOD LOSS WAS FOUND IN THE VENOUS VENTING LINE SEVEN DAYS INTO THE TREATMENT. AGAIN, THE VENTING LINE WAS CLAMPED AND TREATMENT CONTINUED. THE CAUSE OF THE HAIRLINE FRACTURES WAS UNKNOWN. THE PRODUCT WAS STILL IN USE WHEN THE EVENT WAS REPORTED. NO FURTHER INFORMATION ABOUT THE PROGRESS OF THE TREATMENT WAS PROVIDED. DUE TO THE HAIRLINE FRACTURES, ESTIMATED BLOOD LOSS (EBL) WAS REPORTED TO BE 150 ML TOTAL. THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS EXPERIENCED, AND NO MEDICAL INTERVENTION THAT WAS REQUIRED DUE TO THE REPORTED EVENT. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND PHOTOS WERE NOT AVAILABLE FOR REVIEW. THOUGH PATIENT INFORMATION WAS REQUESTED, THE MANUFACTURER INDICATED THAT IT WAS NOT AVAILABLE. THIS REPORT CAPTURES THE HAIRLINE FRACTURE AND LEAK THAT WAS OBSERVED IN THE ARTERIAL VENTING LINE.

    Additional Manufacturer Narrative · 1

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO WAS PLACED ON VENO-VENOUS (VV) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY EXPERIENCED BLOOD LOSS DUE TO A HAIRLINE FRACTURE FOUND IN THE ARTERIAL VENTING LINE OF THE XLUNG KIT A FEW HOURS AFTER TREATMENT INITIATION. THE DEVICE WAS INSPECTED FOR DAMAGE PRIOR TO USE AND NO DAMAGE WAS FOUND. THERE WAS NO LEAKING NOTICED DURING THE PRIMING PHASE. THERE WERE NO ALARMS FROM THE CONSOLE ASSOCIATED WITH THE REPORTED EVENT. THERE WAS NO REPORT OF THE XLUNG KIT BEING REPLACED. THE RESOLVE THE REPORTED ISSUE, THE VENTING LINE WAS CLAMPED, AND TREATMENT THEN CONTINUED. A SECOND HAIRLINE FRACTURE WHICH RESULTED IN ADDITIONAL BLOOD LOSS WAS FOUND IN THE VENOUS VENTING LINE SEVEN DAYS INTO THE TREATMENT. AGAIN, THE VENTING LINE WAS CLAMPED AND TREATMENT CONTINUED. THE CAUSE OF THE HAIRLINE FRACTURES WAS UNKNOWN. THE PRODUCT WAS STILL IN USE WHEN THE EVENT WAS REPORTED. NO FURTHER INFORMATION ABOUT THE PROGRESS OF THE TREATMENT WAS PROVIDED. DUE TO THE HAIRLINE FRACTURES, ESTIMATED BLOOD LOSS (EBL) WAS REPORTED TO BE 150 ML TOTAL. THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS EXPERIENCED, AND NO MEDICAL INTERVENTION THAT WAS REQUIRED DUE TO THE REPORTED EVENT. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND PHOTOS WERE NOT AVAILABLE FOR REVIEW. THOUGH PATIENT INFORMATION WAS REQUESTED, THE MANUFACTURER INDICATED THAT IT WAS NOT AVAILABLE. THIS REPORT CAPTURES THE HAIRLINE FRACTURE AND LEAK THAT WAS OBSERVED IN THE ARTERIAL VENTING LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682186 XLUNG KIT 230 QJZ QJZ XENIOS AG 8013714

    Patients

    Seq Age Sex Outcome Treatment
    1 NOVALUNG CONSOLE| NOVALUNG CONSOLE