BEUDAMED
    FDA Adverse Event Summary report: N

    CIRCUIT NEO 4FT HTD W/12IN REMOTE 30/CS

    MDR report key: 3408540 · Received October 14, 2013

    Report

    Report Number
    8030673-2013-00057
    Date Received
    October 14, 2013
    Date of Event
    September 15, 2013
    Report Date
    September 17, 2013
    Manufacturer
    CAREFUSION
    Product Code
    BZE
    PMA / PMN Number
    K915226
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4). IN ADDITION, THE ALARMING CONDITION EXPERIENCED COULD BE CAUSED DUE TO THE NO READING ON THE WIRE OF THE CIRCUIT. AS A CORRECTIVE ACTION, FOR THE CRACK CONDITION ON THE TEMP PROBE, A NEW MATERIAL WAS QUALIFIED (POLYCARBONATE) TO REDUCE THE RISK OF CRACKS ON THESE COMPONENTS. FOR THE PROBLEM FOUND IN THE WIRE OF THE CIRCUIT (NO RESISTANCE OUT OF RANGE AND/OR READING) AN IMPROVEMENT IS BEING QUALIFIED AND VALIDATED. A NEW CLAMP IS BEING QUALIFIED IN ORDER TO HAVE A BETTER/PROPER ASSEMBLY BETWEEN CLAMP AND WIRE AND REDUCE FAILURE ON RESISTANCE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: WE HAVE HAD 4 CIRCUITS THAT PASSED THE PRETEST, BUT WHEN PUT ON THE (B)(6), THE HEATER WOULD NOT HEAT (WOULD NOT GO ABOVE 23C- MR820 HEATER), THE LOW PRESSURE ALARM ALARMED AND THE FLOW SENSOR ALARMED ¿O2 MEASUREMENT OUT OF RANGE¿. THERE WAS NO PATIENT HARM AS THE PATIENTS WERE MANUALLY VENTILATED WHILE THE CIRCUITS WERE IMMEDIATELY SWITCHED TO EVAQUA CIRCUITS WITH NO FURTHER ISSUES. THE LOT NUMBERS WERE NOT KNOWN SINCE THE LABEL WAS DISCARDED, BUT CUSTOMER STATED SHE HAS LOT NUMBERS: 0000453627 AND 0000548191. THE DRAGER VENT WAS USED WITH ALL THESE CIRCUITS. THIS IS REPORT 3 OF 4 OF THE REPORTED DEFECTIVE CIRCUITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525229 CIRCUIT NEO 4FT HTD W/12IN REMOTE 30/CS HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER BZE CAREFUSION RT4851-12

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention