BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVALUNG CONSOLE (LINUX BOARD)

    MDR report key: 14171643 · Received April 21, 2022

    Report

    Report Number
    3012172416-2022-00028
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    December 28, 2021
    Report Date
    April 21, 2022
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    PMA / PMN Number
    K191407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. INVESTIGATION OF THE MACHINE FILES WAS NOT CONSIDERED NECESSARY BECAUSE THE COMPLAINT IS RELATED TO A COMPONENT DEFECT. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. NO DEVIATIONS WERE FOUND DURING THE DEVICE HISTORY RECORD (DHR) REVIEW. HOWEVER, IT WAS FOUND THAT THE SENSOR BOX INCLUDED COMPONENTS WITH A PROBLEMATIC MATERIAL COMBINATION. REVIEW OF THE REPAIR HISTORY WAS NOT REQUIRED. THE SAMPLE WAS NOT RETURNED FOR EXAMINATION AND THE SENSOR BOX WAS REPAIRED AT THE MANUFACTURER¿S WORKSHOP. THE TECHNICIAN CONFIRMED THE SENSOR BOX HAD A DEFECT INDICATING THE GOLD/TIN PROBLEM OUTLINED IN A CAPA THAT WAS OPENED FOR THE FLOW MEASUREMENT ERRORS. THE DESCRIBED SITUATION IS ADEQUATELY ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU). IF THERE IS A TECHNICAL FAILURE OF THE FLOW AND PRESSURE MEASUREMENT, THE IFU INSTRUCTS TO REPLACE THE CONSOLE. BASED ON THE FINDINGS OF THE INVESTIGATION, THE REPORTED EVENT HAS BEEN CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE HOUR INTO A PATIENT¿S EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) TREATMENT, THE NOVALUNG CONSOLE GAVE OUT ERROR CODES #206 AND #208 INDICATING A LOSS OF FLOW MEASUREMENT. IT WAS CONFIRMED THAT NO ALARMS WENT OFF DURING THE PRIMING PHASE. THE OPERATOR TRIED SWITCHING TO THE BACKUP PUMP DRIVE (AND BATTERY PACK) AND RESTARTING THE CONSOLE, BUT THE ERRORS PERSISTED. DUE TO THE ERRORS, THE PATIENT WAS CONNECTED TO A DIFFERENT CONSOLE AND ECMO KIT. REPLACING THE CONSOLE AND KIT RESOLVED THE ISSUE. PER PROCEDURE, THE PATIENT¿S BLOOD WAS NOT RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 670 ML TO 720 ML. THERE WAS NO PATIENT INJURY OR HARM DUE TO THE EVENTS, AND THERE WAS NO INDICATION THAT MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS ABLE TO CONTINUE THEIR TREATMENT. THE SENSOR BOX WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956666 NOVALUNG CONSOLE (LINUX BOARD) QJZ QJZ XENIOS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Female ECMO KIT.