BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCUIT PED 5FT DUAL-HTD 20/CS

    MDR report key: 2596411 · Received June 1, 2012

    Report

    Report Number
    8030673-2012-00141
    Event Type
    Malfunction
    Date Received
    June 1, 2012
    Date of Event
    May 2, 2012
    Report Date
    May 4, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BZE
    PMA / PMN Number
    K915226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) K915226 ADDED TO REPORT. RESULTS OF EVALUATION: THE CUSTOMER RETURNED SAMPLE WAS RECEIVED AND EVALUATED. IT COULD BE CONFIRMED UPON VISUAL INSPECTION THAT THE CLEAR TUBING WAS MELTED. RESISTANCE TESTING WAS PERFORMED ON THE HEATED WIRES IN BOTH THE BLUE AND THE CLEAR TUBING, AND THE RESISTANCE VALUES OF 26.7 OHM (BLUE TUBE) AND 26 OHM (CLEAR TUBE) WERE WITHIN THE SPECIFIED RANGE OF 24 TO 27 OHM. IT WAS NOT POSSIBLE TO REVIEW THE DEVICE HISTORY RECORD BECAUSE A LOT NUMBER WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE FOR THE MELTED TUBING COULD NOT BE DETERMINED. ONE POTENTIAL CAUSE IS THE TEMPERATURE SETTING OF THE HUMIDIFIER. IF THE TEMPERATURE IS SET TOO HIGH BY THE USER, THE WIRE(S) MAY GET TOO HOT AND MELT THE PLASTIC TUBING. AN ALTERNATE POTENTIAL CAUSE WOULD BE THE TUBING PLACED TOO CLOSE TO HUMIDIFIER HEATER AND CONTACTING THE HEATER PLATE. REVIEW OF THE LABELING FOR THIS PRODUCT INDICATES THE FOLLOWING STATEMENTS: "CAUTION DO NOT USE THIS CIRCUIT WHERE GAS TEMPERATURE AT THE OUTLET OF THE HUMIDIFIER EXCEEDS 68 DEGREES CELSIUS. DO NOT USE THE HEATED WIRE CIRCUIT WITHOUT GAS FLOW. DO NOT PLACE MATERIAL ON OR AROUND THE HEATED WIRE TUBING. WARNINGS AVOID CONTACT WITH PATIENT SKIN. DO NOT STRETCH THE TUBING. DO NOT SOAK, RINSE WASH, OR STERILIZE THIS PRODUCT." MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN THIS INVESTIGATION IS COMPLETED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED TO CAREFUSION THAT THE CUSTOMER HAD A HEATED PEDIATRIC RESPIRATORY CIRCUIT THAT MELTED TOGETHER DURING USE. THE CIRCUIT WAS IN USE ON A PATIENT FOR LESS THAN A WEEK WHEN THE MELTING OCCURRED. THE CLINICIAN WAS ALERTED TO THE PROBLEM BY LOW PRESSURE ALARMS FROM THE VENTILATOR. THE CIRCUIT WAS CHANGED OUT TO CORRECT THIS SITUATION. THERE WAS NO ADVERSE EFFECT OR HARM TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCUIT PED 5FT DUAL-HTD 20/CS HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER) BZE CAREFUSION RT509-852 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1