BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2924235 · Received January 22, 2013

    Report

    Report Number
    8030673-2013-00002
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BZE
    PMA / PMN Number
    K915226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION. IT WAS VISUALLY INSPECTED AND WE OBSERVED SIGNS OF CRAZING (SPIDER-WEB LIKE MARKINGS), BUT NO CRACKS. THE PRODUCTION RECORD FOR THE BATCH REPORTED WAS EVALUATED AND NO ISSUES WERE OBSERVED. AT THIS TIME IT IS NOT POSSIBLE TO DETERMINE IF THE MATERIAL OF THE 'Y' IS CAUSING THE LOOSE CONDITION REPORTED. HOWEVER A PROJECT IS BEING OPENED TO FIND A ROOT CAUSE FOR THE CRAZING CONDITION OF THE 'Y' MADE OF POLYCARBONATE RESIN. THE PROJECT HAS BEEN OPENED AND THE INVESTIGATION IS ONGOING TO IDENTIFY AND ADDRESS THE PROBABLE ROOT CAUSE AND TO DEVELOP AN APPLICABLE ACTION PLAN. THE PRELIMINARY PLAN PROPOSES OPTIMIZATION OF THE MOLDING PARAMETERS AND IMPLEMENTATION OF A STRESS TEST OF ALL INCOMING RAW MATERIAL.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED: I RECEIVED ANOTHER DEFECTIVE CIRCUIT.  THIS ONE HAD A LOOSE CONNECTION AT THE SIDE PORTS.  THERE IS A SMALL CRACK ON ONE OF THE LIMBS TOO.  THE LOT# IS 459203. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013: THERE WAS A COMPLETE DISCONNECT ON BOTH PORTS OF THE CIRCUIT CAUSING THE DISCONNECT ALARM (IN GENERAL THAT IS HOW ALL LOOSE CONNECTIONS ARE DISCOVERED). THE DISCONNECT ALARM ALARMED AND THE CIRCUIT WAS IN USE FOR 6 DAYS. AN ETCO2 ADAPTOR WAS USED WITH THE CIRCUIT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. NO PATIENT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30368 CIRCUIT NEO 4FT HTD W/12IN REMOTE 30/CS HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER BZE CAREFUSION RT4851-12 459203

    Patients

    Seq Age Sex Outcome Treatment
    1