BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCUIT NEONATE 4FT HTD W/ 30/CS

    MDR report key: 2853379 · Received November 30, 2012

    Report

    Report Number
    8030673-2012-00244
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 5, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BZE
    PMA / PMN Number
    K915226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE OPENED SAMPLE WAS AVAILABLE FOR EVALUATION. UPON VISUAL INSPECTION, THE CRACK WAS CONFIRMED ON THE PLASTIC STRAIGHT CONNECTOR. IT WAS CONFIRMED THAT THE FAILURE MODE WAS TO BE THE MOLDING PROCESS VARIABILITY AT THE SUPPLIER. A REVIEW OF THE PRODUCTION RECORD WAS PERFORMED AND INDICATED THAT THE PRODUCT WAS MADE OF K-RESIN MATERIAL. CAREFUSION HAS IMPLEMENTED A PROJECT PLAN OF A MATERIAL CHANGE TO POLYCARBONATE MATERIAL IN THE EFFORTS TO DECREASE THE LIKELIHOOD OF CRACKING. THE PRELIMINARY PLAN PROPOSES OPTIMIZATION OF THE MOLDING PARAMETERS AND IMPLEMENTATION OF A STRESS TEST OF ALL INCOMING RAW MATERIAL. THE SAMPLE RECEIVED FOR THIS COMPLAINT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THESE CORRECTIONS.

    Additional Manufacturer Narrative · 1

    (B)(4): THE SAMPLE WAS RECEIVED FOR EVALUATION. UPON COMPLETION OF CAREFUSION'S INVESTIGATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE PRODUCT IS CRACKING IN THE CLEAR PLASTIC STRAIGHT CONNECTOR THAT JOINS THE CORRUGATED CIRCUIT TUBING TO THE PATIENT CONNECTION ADAPTER. CUSTOMER REPORTS THAT, IT IS NOT THE PATIENT CONNECTION ADAPTER THAT IS CRACKING BUT THE PLASTIC PIECE THAT FITS INTO THE PATIENT CONNECTION ADAPTER. THE CUSTOMER ADVISED WHEN THE PIECE CRACKED, IT CAUSED A COMPLETE DISCONNECT OF THE CIRCUIT. ONCE CRACKED, THE CIRCUIT BECOMES COMPLETELY OPEN. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCUIT NEONATE 4FT HTD W/ 30/CS HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER BZE CAREFUSION RT4851-00 0000453595

    Patients

    Seq Age Sex Outcome Treatment
    1