BEUDAMED
    FDA Adverse Event Summary report: N

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

    MDR report key: 3408542 · Received October 14, 2013

    Report

    Report Number
    8030673-2013-00058
    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

    (B)(4). EVALUATION SUMMARY:THE CUSTOMER RETURNED (B)(4) UNITS FOR EVALUATION. (B)(4) UNOPENED SAMPLES FROM LOT 0000548191, (B)(4) UNOPENED SAMPLES FROM LOT 0000453627 AND (B)(4) OPEN UNITS WITH NO LOT NUMBER IDENTIFICATION. THE (B)(4) UNOPENED SAMPLES WERE EVALUATED IN ACCORDANCE WITH OUR PROCEDURE AND THE RESULTS ARE AS FOLLOWS: (B)(4) SAMPLES WERE FOUND ACCEPTABLE DURING THE RESISTANCE AND LEAK TESTS AND ONE SAMPLE DID NOT PASS THE RESISTANCE TEST (LOT 0000453627). READING WAS 28.6 AND THE SPECIFICATION IS FROM 24 TO 27 OHMS. NO ISSUES WERE FOUND DURING THE LEAK TEST. IN ADDITION, NO VISUAL DEFECTS WERE FOUND IN THE (B)(4) SAMPLES. THE (B)(4) OPEN SAMPLES WERE ALSO EVALUATED AND PER VISUAL INSPECTION COMPONENT (TEMP PROBE) WAS FOUND CRACKED ON ALL (B)(4) OPEN SAMPLES. ONE OF THESE UNITS FAILED THE RESISTANCE TEST (NO READING). THE TEMP PROBE COMPONENTS WERE SENT TO OUR LABORATORY AND PER IR SCAN (INFRARED SPECTRUM) IT IDENTIFIED THAT THE COMPONENTS WERE MADE OF K RESIN. AT THIS TIME, THERE IS NOT ANY EVIDENCE THAT CONFIRMS THAT OUR OPERATIVE PERSONNEL ARE CONTRIBUTING TO THIS FAILURE. DURING THE MANUFACTURING REVIEW, IT WAS OBSERVED THAT THIS PRODUCT IS 100% TESTED BY RESISTANCE FUNCTION AND NO ISSUES WERE OBSERVED. IN ADDITION, NO ASSEMBLY ERRORS WERE OBSERVED DURING CURRENT PRODUCTION PROCESS. NO LOT NUMBERS WERE AVAILABLE FOR THE (B)(4) CIRCUITS REPORTED. HOWEVER, LOT NUMBERS 0000453627 AND 0000548191 WERE OBSERVED FROM RETURNED SAMPLES. THE DEVICE HISTORY RECORD OF THESE LOTS WAS REVIEWED AND NO ISSUES WERE OBSERVED RELATED TO THIS CUSTOMER REPORT. BASED ON THE SAMPLE EVALUATION, CAREFUSION CONCLUDED THAT THE ALARMING CONDITION EXPERIENCED WITH THE CIRCUITS WAS CAUSED DUE TO THE CRACKS ON THE TEMP PROBE COMPONENT MATERIAL. 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 4 OF 4 OF THE REPORTED DEFECTIVE CIRCUITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525527 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