BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLUNG KIT 230

    MDR report key: 11741421 · Received April 28, 2021

    Report

    Report Number
    3012172416-2021-00010
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 30, 2021
    Report Date
    May 26, 2021
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    PMA / PMN Number
    K191407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    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. 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 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 · 0

    A PATIENT WHO WAS PLACED ON VENO-VENOUS (VV) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY EXPERIENCED BLOOD LOSS DUE TO A HAIRLINE CRACK IN THE "POS OXY TUBE" [SIC]. THE EVENT OCCURRED ON DAY 4 OF ECMO THERAPY. THE DEVICE WAS INSPECTED FOR DAMAGE PRIOR TO USE. THERE WAS NO LEAKAGE NOTED DURING THE PRIMING. THERE WERE NO ALARMS AT THE CONSOLE ASSOCIATED WITH THE EVENT. A TECHNICAL DRAWING OF THE OXYGENATOR WAS PROVIDED FOR CONTEXT, AND IN THAT DRAWING, THE LOCATION OF THE CRACKED TUBING WAS CIRCLED. BASED ON THE DRAWING, THE HAIRLINE CRACK WAS IDENTIFIED ON THE SAMPLING LINE FOR THE POST OXYGENATOR LAB TESTING. TO RESOLVE THE ISSUE, THE LINE WAS CLAMPED AND THE TREATMENT WAS CONTINUED WITH THE SAME PRODUCT; NO PRODUCTS HAD TO BE REPLACED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS 100 ML. THERE WERE NO ADVERSE EVENTS, SYMPTOMS, OR MEDICAL INTERVENTION THAT WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT'S ULTIMATE OUTCOME WAS UNKNOWN. HOWEVER, IT WAS STATED THAT THE EVENT DID NOT AFFECT THE PATIENT AS THE HAIRLINE FRACTURE WAS QUICKLY NOTICED AND THE BLOOD LOSS WAS LOW. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. DATA RELATED TO THE PERFUSION PROTOCOL WAS NOT PROVIDED AND THE LOGFILE OF THE CONSOLE WAS REPORTEDLY UNAVAILABLE.

    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

    A PATIENT WHO WAS PLACED ON VENO-VENOUS (VV) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY EXPERIENCED BLOOD LOSS DUE TO A HAIRLINE CRACK IN THE "POS OXY TUBE" [SIC]. THE EVENT OCCURRED ON DAY 4 OF ECMO THERAPY. THE DEVICE WAS INSPECTED FOR DAMAGE PRIOR TO USE. THERE WAS NO LEAKAGE NOTED DURING THE PRIMING. THERE WERE NO ALARMS AT THE CONSOLE ASSOCIATED WITH THE EVENT. A TECHNICAL DRAWING OF THE OXYGENATOR WAS PROVIDED FOR CONTEXT, AND IN THAT DRAWING, THE LOCATION OF THE CRACKED TUBING WAS CIRCLED. BASED ON THE DRAWING, THE HAIRLINE CRACK WAS IDENTIFIED ON THE SAMPLING LINE FOR THE POST OXYGENATOR LAB TESTING. TO RESOLVE THE ISSUE, THE LINE WAS CLAMPED AND THE TREATMENT WAS CONTINUED WITH THE SAME PRODUCT; NO PRODUCTS HAD TO BE REPLACED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS 100 ML. THERE WERE NO ADVERSE EVENTS, SYMPTOMS, OR MEDICAL INTERVENTION THAT WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT'S ULTIMATE OUTCOME WAS UNKNOWN. HOWEVER, IT WAS STATED THAT THE EVENT DID NOT AFFECT THE PATIENT AS THE HAIRLINE FRACTURE WAS QUICKLY NOTICED AND THE BLOOD LOSS WAS LOW. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. DATA RELATED TO THE PERFUSION PROTOCOL WAS NOT PROVIDED AND THE LOGFILE OF THE CONSOLE WAS REPORTEDLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638364 XLUNG KIT 230 QJZ QJZ XENIOS AG 8013886

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR NOVALUNG CONSOLE| NOVALUNG CONSOLE