BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASK AIR ENTRAIN ADULT 50/CS

    MDR report key: 2925674 · Received January 22, 2013

    Report

    Report Number
    8030673-2013-00003
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    CAREFUSION
    Product Code
    BYF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE IS IN THE PROCESS OF BEING SENT TO MANUFACTURING PLANT. UPON COMPLETION OF CAREFUSION'S INVESTIGATION, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, WE CONFIRMED THE 50% VENTI ADAPTER TO BE OCCLUDED. THE ADAPTER IS A SUPPLIED COMPONENT TO CAREFUSION. THE SUPPLIER THAT MANUFACTURES THIS PART WAS NOTIFIED OF THE DEFECT. A PROJECT INITIATION WAS REQUESTED TO THE SUPPLIER BY CAREFUSION TO DETERMINE THE ROOT CAUSE FOR THE ADAPTER BEING OCCLUDED. IN ADDITION, CAREFUSION PLANS TO IMPLEMENT ADDITIONAL QUALITY INSPECTIONS AT THE ASSEMBLY LINE PROCESS IN ORDER TO IMMEDIATELY DETECT THIS TYPE OF FAILURE IF IT WERE TO RECUR.

    Additional Manufacturer Narrative · 1

    (B)(4):CAREFUSION RECEIVED FACILITY MEDWATCH ON (B)(4) 2013. THE FOLLOWING INFORMATION WAS PROVIDED, "THE 50% FIO2 ADAPTER PIECE OF THE OXYGEN KIT DID NOT ALLOW FOR OXYGEN TO FLOW THROUGH AND THE PATIENT DESATURATED. NO PATIENT HARM BUT THE RESPIRATORY TECH DISCOVERED THAT THERE IS NO HOLE IN THAT PIECE. ALL OTHER PIECES ARE FINE. MULTIPLE FAILURES HAVE BEEN FOUND IN THIS ONE LOT." UPON COMPLETION OF CAREFUSION'S INVESTIGATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT ON (B)(6) 2013, AN ISSUE WAS OBSERVED WITH THE CARDINAL HEALTH OXYGEN MASK 001240 LOT 000493387. THERE IS NO OPENING FOR OXYGEN TO GO THROUGH WHEN THE MASK IS SET AT 50% ADAPTER WHERE THE LINE CONNECTS TO THE VENTURI ADAPTER. CUSTOMER IS IN THE PROCESS OF PULLING ALL OF THE MASKS TO CHECK THEIR PATENCY ON ALL SETTINGS. SAMPLES WILL BE RETURNED FOR EVALUATION. CUSTOMER STATED THAT THERE WAS NO LASTING PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON (B)(6) 2013: THE ,50 VENTI MASK WAS SET UP ON A PATIENT WHEN THE THERAPIST RECOGNIZED THERE WAS NO FLOW COMING OUT. IT WAS RECOGNIZED THAT THERE WAS NO PATENCY IN THE .50 VENTI CLIP. THE THERAPIST RECOGNIZED THE ISSUE IMMEDIATELY. THE HOSPITAL STAFF PULLED ALL THE PRODUCT FROM THEIR SHELVES AND STOCK AND NO LONGER WISHES TO USE THIS PRODUCT. THERE REMAINS 5 CASES OF PRODUCT IN THEIR DEPARTMENT WITH TWO SEPARATE LOT NUMBERS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30427 MASK AIR ENTRAIN ADULT 50/CS MASK, OXYGEN, LOW CONCENTRATION, VENTURI BYF CAREFUSION 001240-A 000493387

    Patients

    Seq Age Sex Outcome Treatment
    1