BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODUCT VYNTUS CPX TABLE

    MDR report key: 16245948 · Received January 26, 2023

    Report

    Report Number
    9615102-2023-00131
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 4, 2023
    Report Date
    January 26, 2023
    Manufacturer
    VYAIRE MEDICAL GMBH
    Product Code
    BZC
    UDI-DI
    04250892905983
    PMA / PMN Number
    K183567
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TWIN TUBE WAS NOT RETURNED TO THE MANUFACTURER AS THE CUSTOMER HAD ALREADY DISPOSED OF THE COMPONENT. THE CUSTOMER INFORMED VYAIRE THAT THEY USED A DISINFECTION PROCESS/MATERIAL THAT HAD NOT BEEN RECOMMENDED BY VYAIRE AND IS NOT WITHIN THE PH THRESHOLD DEFINED IN VYAIRE'S HYGIENE INSTRUCTION MANUAL. DURING THE INVESTIGATION IT COULD NOT BE CONFIRMED WHETHER OR NOT THE CUSTOMER'S DISINFECTION METHOD CONTRIBUTED TO THE INCIDENT. INFORMATION FROM THE INVESTIGATION INDICATED THAT IN SOME CASES THE GLUE USED TO ATTACH THE PARTS OF THE TWIN TUBE COULD POTENTIALLY BE INSUFFICIENTLY APPLIED AND DISTRIBUTED IN CERTAIN AREAS. AS A RESULT OF THE INFORMATION FROM THE INVESTIGATION A SHIP HOLD OF THE TWIN TUBE WAS INITIATED ON (B)(6) 2023. AS A PART OF CAPA-000001051 AN ENGINEERING CHANGE REQUEST (ECR) WAS INITIATED TO IMPROVE THE APPLICATION AND DISTRIBUTION OF GLUE IN THE MANUFACTURING PROCESS. AS AN ADDITIONAL MEASURE INCLUDED IN THE ECR A PULL-TEST HAS BEEN INITIATED TO PHYSICALLY CHECK THE STRENGTH OF GLUED PARTS IN THE PRODUCTION PROCESS. A FINAL RISK ASSESSMENT WILL BE REQUESTED FROM THE CLINICAL RISK MANAGEMENT ONCE THE CAPA INVESTIGATION IS FINISHED TO DETERMINE FURTHER ACTIONS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION INTO THIS MATTER. VYAIRE'S GLOBAL CUSTOMER SERVICE STAFF MEMBER TOLD THE CUSTOMER TO TAKE THE TWIN TUBE OUT OF USE AND TO RETURN IT TO THE MANUFACTURER FOR INVESTIGATION. UNFORTUNATELY, THE CUSTOMER HAS DISPOSED OF THE TWIN TUBE ALREADY. SO, NO TECHNICAL INVESTIGATION ON THE COMPONENT IS POSSIBLE. THE CUSTOMER HAS BEEN CONTACTED TO PROVIDE MORE DETAILS ABOUT THE FOLLOWING: THE DISINFECTION METHOD, DISINFECTION FREQUENCY, DISINFECTION AGENT, THE OVERALL TIME PERIOD WHEN THE TWIN TUBE WAS USED, THE FREQUENCY OF USE AND THE AGE OF THE TWIN TUBE. THE CUSTOMER ANSWERED THE QUESTIONS ON JANUARY 25. R&D DEPARTMENT WILL INVESTIGATE THE ISSUE FURTHER. A CAPA REQUEST WAS ISSUED AND WILL BE PROCESSED (INTERNAL IDENTIFICATION NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE WAS REVEALED TO BE DUE TO INSUFFICIENT DOCUMENTED MANUFACTURING PROCESS. THE GLUING PROCESS WAS NOT CLEARLY DESCRIBED IN THE WORK INSTRUCTIONS. THERE WAS ALSO NO AUTOMATED OR MANUAL PULL TEST FOR THE TIP OF THE TWIN TUBE. THE INVESTIGATION REGARDING THIS ISSUE IS CLOSED. THE RISK ASSESSMENT REGARDING THE OUTCOME OF AIRWAY OBSTRUCTION RESULTED IN AN IDENTIFICATION OF A RISK WITH A CRITICAL SEVERITY OF HARM AND A REMOTE PROBABILITY OF THE HAZARDOUS OUTCOME OCCURRING. THE RISK MITIGATION IS CLASSIFIED AS A FIELD SAFETY CORRECTIVE ACTION (TENTATIVE REFERENCE NO. (B)(4)) WHICH WILL BE A FIELD SAFETY NOTIFICATION WITH COMMUNICATION INFORMING CUSTOMERS REGARDING THE ISSUE AND APPROPRIATE ACTIONS TO MITIGATE THE LIKELIHOOD OF OCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT A PATIENT EXPERIENCED AN ISSUE WHILE CONNECTED TO VYNTUS CPX. THE CUSTOMER STATED THAT DURING THE SPIROMETRY PROCEDURE BEFORE THE ACTUAL ERGO SPIROMETRY, THE PATIENT WAS INSTRUCTED TO PERFORM A DEEP INHALATION. AT THAT POINT, THE PATIENT SUDDENLY HAD A PIECE OF FOREIGN MATERIAL IN HER MOUTH AND ALMOST SWALLOWED IT. THE CUSTOMER CONFIRMED THAT THE PATIENT SPIT THE FOREIGN MATERIAL OUT AND IT TURNED OUT TO BE A PIECE OF THE TWIN TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959490 PRODUCT VYNTUS CPX TABLE VYNTUS CPX BZC VYAIRE MEDICAL GMBH VYNCPX/T 04250892905983

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention