BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE

    MDR report key: 12054634 · Received June 23, 2021

    Report

    Report Number
    3002807637-2021-00020
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 27, 2021
    Report Date
    May 27, 2021
    Product Code
    CBL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: THE PRODUCTION REPORT REVIEW SHOWED NO DEVIATIONS TO THE SPECIFICATION OF THE DEVICE DURING MANUFACTURE. ALL UNITS PACKED PASSED 100% LEAK TEST AND VISUAL INSPECTION. A REVIEW OF THE BATCH DOCUMENTATION FOR THE LOT LO1A-00146 AND 5090720 FOUND NO ISSUES THAT COULD BE LINKED WITH DAMAGE FAILURES ON THESE BATCHES. PALLET AND CARTON FOR CANISTERS CLEARLY STATE THAT THEY ARE FRAGILE AND TO HANDLE WITH CARE. DEVICES ARE PACKAGED IN A CARTON THAT MEETS THE VYAIRE DROP TESTING SPECIFICATION. HOWEVER, AS NO PHOTOGRAPHIC EVIDENCE HAS BEEN SUPPLIED, IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE FAILURE. CORRECTIVE/PREVENTIVE ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THE REPORTED FAILURE AND ARE DETAILED UNDER CAPA 21-013.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. BUT THE DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. HOWEVER, AT THIS TIME, NO ROOT CAUSE COULD BE DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK ON 8003138 MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE. THE MAC VALUE IS OVER 700, AND THEREFORE TOO MUCH OXYGEN IS ESCAPING. THERE WAS NO PATIENT HARM REPORTED IN THIS COMPLAINT. TESTS/LAB DATA, INCLUDING DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951773 MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE ABSORBENT, CARBON-DIOXIDE CBL MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE LO1A-00146 AND 5090720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention