BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISORB EX

    MDR report key: 17807840 · Received September 25, 2023

    Report

    Report Number
    3010838917-2023-00081
    Event Type
    Injury
    Date Received
    September 25, 2023
    Date of Event
    August 30, 2023
    Report Date
    September 25, 2023
    Manufacturer
    VYAIRE OY
    Product Code
    CBL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. FAILURE WAS CONFIRMED, DUE TO A LEAK FROM DAMAGED LID. ROOT CAUSE COULDN'T BE DETERMINED. REVIEWED SHA - RMF-HL-0053 - CO2 ABSORPTION PRODUCTS AND COMPONENTS - MDD - REV07 - 12-DEC-2023. CLOSEST RISK SHA-HL-0053-035 EXCESSIVE CARBON DIOXIDE OR CARBON DIOXIDE BUILD UP DURING VENTILATION (INSUFFICIENT CARBON DIOXIDE REMOVAL) POSSIBLE CAUSES BEING CO2 IS NOT ABSORBED BECAUSE: REUSE OF SODA LIME, TOO LONG USE, DEFECT ON USE, DEFECT ON ABSORBER, SUPPLIER INVESTIGATION SUGGESTS DEFECT ON ABSORBER.

    Additional Manufacturer Narrative · 0

    H3: 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN 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 · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 79796-001 MEDISORB EX, PKG OF 6 PCS WASN'T ABSORBING CO2 WHILE CONNECTED TO THE PATIENT. THE DEFECTIVE CANISTER WAS IMMEDIATELY REMOVED AND WAS REPLACED WITH A NEW ONE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 79796-001 MEDISORB EX, PKG OF 6 PCS WASN'T ABSORBING CO2 WHILE CONNECTED TO THE PATIENT. THE DEFECTIVE CANISTER WAS IMMEDIATELY REMOVED AND WAS REPLACED WITH A NEW ONE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421763 MEDISORB EX MEDISORB EX, PKG OF 6 PCS CBL VYAIRE OY 2079796-001 L0LA-01510

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention