BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCUIT NEONATE 4FT HTD W/ 30/CS

    MDR report key: 2842962 · Received November 21, 2012

    Report

    Report Number
    2050001-2012-00041
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 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): CORRECTION: ONE SAMPLE WAS RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4): THREE SAMPLES WERE RECEIVED FOR EVALUATION. THE SAMPLES WERE CONFIRMED TO BE CRACKED AND A PIECE OF PLASTIC REMAINED IN THE WYE. THE FAILURE MODE WAS DUE TO THE MOLDING PROCESS VARIABILITY AT THE SUPPLIER. A REVIEW OF THE PRODUCTION RECORD WAS PERFORMED AND THE REVIEW INDICATED THAT THE PRODUCT WAS MADE OF (B)(4) MATERIAL. CAREFUSION HAS IMPLEMENTED A PROJECT PLAN OF A MATERIAL CHANGE TO (B)(4) 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 HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF CAREFUSION INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE INSPIRATORY PIECE (CLEAR PLASTIC) THAT FITS INTO THE PATIENT CONNECTION ADAPTER OF THE CIRCUIT IS CRACKING. THE MALE PORTION OF THIS COMPONENT REMAINS IN THE PATIENT CONNECTION ADAPTER CAUSING A DISCONNECTION, AND THEREFORE THEY NEED TO REPLACE THE ENTIRE CIRCUIT TO RESOLVE THE ISSUE. THE CLINICIAN MOVES THE PATIENT AND THEN NOTICES THE HISSING NOISE. NO PATIENT INJURY/IMPACT WAS REPORTED.

    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