BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCUIT NEONATE 4FT HTD W/ 30/CS

    MDR report key: 2842960 · Received November 21, 2012

    Report

    Report Number
    8030673-2012-00240
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 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): TWO 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. DURING INSPECTION OF THE SAMPLES IT WAS CONFIRMED THAT THE UNITS RECEIVED WERE ALSO 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. A LOT NUMBER WAS NOT PROVIDED THEREFORE A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    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

    THE CUSTOMER REPORTED TO THAT THE CLEAR PLASTIC STRAIGHT CONNECTOR THAT FITS INTO THE INSPIRATORY PIECE AND CONNECTS TO THE PATIENT CONNECTION ADAPTER OF THE CIRCUIT IS CRACKING OFF. THE MALE PORTION OF THIS COMPONENT REMAINS IN THE THE PATIENT CONNECTION ADAPTER AND THEREFORE THEY NEED TO REPLACE THE ENTIRE CIRCUIT TO RESOLVE THE ISSUE. SHE ADVISED THAT BOTH OF THESE CIRCUITS CRACKED DURING PATIENT USE. THE CLINICIAN MOVES THE PATIENT AND THEN NOTICES THE HISSING NOISE. SOON AFTER A HISSING IS HEARD, THE PART COMPLETELY CRACKS (DISCONNECTS) AND THE CIRCUIT MUST BE REPLACED. THE VENTILATOR THEN ALARMS BECAUSE OF THE LOSS OF PRESSURE. THE CLINICIAN IS ABLE TO CATCH THE ISSUE FAIRLY QUICKLY AND REPLACE THE CIRCUIT. THERE IS NO PATIENT INJURY/IMPACT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1