BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYAIRE

    MDR report key: 18008557 · Received October 25, 2023

    Report

    Report Number
    9615102-2023-00143
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    February 2, 2023
    Report Date
    October 25, 2023
    Manufacturer
    VYAIRE MEDICAL GMBH
    Product Code
    CAH
    UDI-DI
    14250892903115
    PMA / PMN Number
    K111408
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED WITH DELAY BECAUSE THE INCIDENT HAPPENED IN GERMANY AND IS NOT REPORTABLE IN THE EU BUT IN THE UNITED STATES. THE REPORTABILITY IN THE US HAS INITIALLY BEEN OVERLOOKED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IT HAS BEEN CONFIRMED THAT THE FILTER INLAY WAS MISSING IN ONE OF THE MICROGARD FILTERS. THIS INFORMATION WAS FORWARDED TO THE SUPPLIER (B)(4) GMBH & CO. KG. NO REPORTABLE ADVERSE EVENT HAPPENED AS THERE WAS NO PATIENT INVOLVEMENT. A CLINICAL RISK ASSESSMENT WAS REQUESTED AND RESULTED IN A POSSIBLE CRITICAL SEVERITY OF HARM. THE PROBABILITY OF THE SITUATION LEADING TO THE HARM (P2) IS SOMEWHAT LIKELY. THUS, THIS MALFUNCTION IS REPORTABLE TO THE FDA AS IT IS NOT UNLIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THE SUPPLIER (B)(4) GMBH & CO. KG. PROVIDED A STATEMENT REGARDING THE MITIGATION MEASURES FOR EACH PRODUCTION LINE. IT HAS BEEN CONFIRMED THAT ALL THREE PRODUCTION LINES HAVE BUILT-IN AND EFFECTIVE MITIGATION MEASURES TO AVOID THE PRODUCTION FROM FILTERS WITHOUT BACTERIAL/VIRAL FILTER INLAY. NO SCAR NECESSARY FOR SUPPLIER (B)(4) GMBH & CO. KG. CORRECTIVE AND PREVENTIVE ACTIONS WERE IMPLEMENTED BY THE SUPPLIER ON 01/26/2022. THE AFFECTED FILTER WAS PRODUCED BEFORE THE IMPLEMENTATION DATE. ALL OTHER PRODUCTION LINES PRODUCED MICROGARD FILTERS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE THAT THE CUSTOMER (B)(6) GMBH RECEIVED A DELIVERY FROM VYAIRE WITH TWO MICROGARD FILTERS THAT WERE INCOMPLETE. IT WAS STATED THAT THE FILTER INLAY WAS MISSING FOR ONE FILTER, AND THE OTHER WAS MISSING 1/2 OF THE FILTER HOUSING. THE FILTERS WERE IDENTIFIED AND RETURNED TO VYAIRE FOR ANALYSIS. THE FILTERS WERE RETURNED INSIDE THEIR ORIGINAL & SEALED PACKAGING; THERE IS NO INDICATION THAT INCOMPLETE FILTERS WERE USED FOR PATIENT MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579245 VYAIRE FILTER, BACTERIAL, BREATHING-CIRCUIT CAH VYAIRE MEDICAL GMBH V-892380 RH 211786-01 14250892903115

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other