BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLUNG KIT 230

    MDR report key: 11646083 · Received April 9, 2021

    Report

    Report Number
    3012172416-2021-00007
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    February 5, 2021
    Report Date
    April 9, 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 COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING THE VISUAL EVALUATION, A SMALL GAP WAS FOUND BETWEEN THE ROTOR AND INNER CASING. IN ADDITION, IRREGULARITIES WERE VISIBLE ON THE BALL BEARING OF THE ROTOR. AFTER OPENING THE PUMP HEAD, SCRATCH MARKS WERE NOTED ON THE INNER AND OUTER HOUSING. IT WAS ALSO NOTED THAT THE CERAMIC BALL WAS SUNK INTO THE ROTOR, AND MELTED MATERIAL (A MIXTURE OF ADHESIVE AND PLASTIC) WAS FOUND AROUND THE BALL. CONSOLE DATA FROM THE EVENT DATE WAS THEN REVIEWED. THE START-UP PROCESS RAN SMOOTHLY WITHOUT ANY ERROR MESSAGES OCCURRING, AND NO ISSUES WERE ENCOUNTERED DURING THE PRIMING PHASE. THE CALIBRATION OF THE FLOW SENSOR WAS CORRECT, AND THE START PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. WHEN THE PUMP DRIVE SPEED WAS INCREASED TO 9600 RPM, AN AIR BUBBLE ALARM OCCURRED. THIS INDICATES TINY AIR BUBBLES ARE BETWEEN THE CAPILLARIES OF THE GAS EXCHANGE MEMBRANE. THE AIR BUBBLES ARE RELEASED WHEN THE FLOW RATE INCREASES. FLOW AND POWER CONSUMPTION WERE WITHIN SPECIFICATION WHEN THE PUMP REACHED THIS SPEED. DURING THE ENTIRE PROCEDURE, NO ERROR MESSAGES OCCURRED THAT WERE RELATED TO THE PUMP DRIVE. EXAMINATION OF THE MANUFACTURING DOCUMENTATION SHOWED NO EVIDENCE OF A DEVIATION. EXAMINATION OF THE PUMP HEAD SHOWED THAT THE BALL BEARING OF THE ROTOR WAS DAMAGED DUE TO OVERHEATING. THE SCRATCH MARKS ON THE INNER AND OUTER CASING COULD HAVE BEEN CAUSED BY THE SINKING OF THE ROTOR OR BY AN IMBALANCE IN THE ROTATION. OVERHEATING CAN OCCUR WHEN A LARGE VOLUME OF AIR IS SUCKED INTO THE PUMP HEAD, BUT THERE WAS NO INDICATION OF THIS FOUND IN THE CONSOLE LOG DATA, AND NO REASON FOR THE NOISE COULD BE FOUND. THE PUMP DRIVE OPERATED ACCORDING TO SPECIFICATION AND THE REPORTED COMPLAINT IS JUSTIFIED. HOWEVER, AN EXACT CAUSE FOR THE DESCRIBED PROBLEM COULD NOT BE FOUND. DUE TO THE DAMAGED PUMP HEAD, A POSSIBLE ORIGINAL FAULT IN THE PRODUCT CAN NO LONGER BE TRACED.

    Description of Event or Problem · 1

    AFTER STARTING THE PUMP DRIVE, CLEAR AUDIBLE NOISES WERE HEARD COMING FROM THE PUMP HEAD AT 3000 REVOLUTIONS PER MINUTE (RPM). A VISUAL INSPECTION OF THE PUMP HEAD DID NOT REVEAL ANY OBVIOUS DEFECT. ACCORDING TO THE USER, THE NOISES CAME FROM THE PUMP HEAD AND NOT FROM THE PUMP DRIVE. UPON FOLLOW-UP, IT WAS CONFIRMED THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON EVALUATION OF THE PUMP HEAD BY THE MANUFACTURER, THE BALL BEARING OF THE ROTOR WAS FOUND TO BE DAMAGED FROM OVERHEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542785 XLUNG KIT 230 QJZ QJZ XENIOS AG 8013747

    Patients

    Seq Age Sex Outcome Treatment
    1