BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT RESP CIRC UNHTD 4FT

    MDR report key: 2350056 · Received November 28, 2011

    Report

    Report Number
    8030673-2011-00055
    Event Type
    Malfunction
    Date Received
    November 28, 2011
    Date of Event
    October 26, 2011
    Report Date
    October 26, 2011
    Manufacturer
    CAREFUSION
    Product Code
    BZE
    PMA / PMN Number
    K915226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT 3 OF 10 SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. UPON COMPLETION OF CAREFUSION'S INVESTIGATION AND/OR RECEIPT OF ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: DEVICE WAS NOT AVAILABLE FOR EVALUATION. INVESTIGATION RESULTS: NO RETURN SAMPLES WERE RECEIVED FOR EVALUATION. THIS TYPE OF FAILURE HAS BEEN CONFIRMED DURING SAMPLE EVALUATION IN PREVIOUS COMPLAINTS. THE DEVICE HISTORY RECORD OF LOT REPORTED WAS REVIEWED AND NO ISSUES RELATED WITH THIS REPORT WERE OBSERVED, PRODUCT WAS PRODUCED AND RELEASED ACCORDING TO OUR INTERNAL PROCEDURES. THE MANUFACTURING PROCESS FOR THIS CIRCUIT, PART # 4914-503 COULD NOT BE VERIFIED BECAUSE THIS CATALOG NUMBER IS NOW OBSOLETE. (B)(4) . THE ROOT CAUSE HAS NOT YET BEEN DETERMINED; (B)(4) WAS INITIATED TO ADDRESS THE POTENTIAL CAUSES FOR THIS PROBLEM AND TO COMPLETE THE FAILURE INVESTIGATION WITH CORRECTIVE ACTIONS IMPLEMENTATION. A MATERIAL CHANGE IS BEING STUDIED IN ORDER TO CONSIDER USING A RESIN WITH MORE RESISTANCE TO SOLVENTS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO CAREFUSION SALES REPRESENTATIVE A PROBLEM WITH THE WYE CONNECTORS ON THEIR VENTILATION CIRCUITS. THE CUSTOMER ADVISED DURING THEIR WEEKLY CHECK OF VENTILATORS, THEY DISCOVERED WYE CONNECTORS THAT ARE CRACKED. THIS INFORMATION WAS REVIEWED WITH THE RESPIRATORY THERAPISTS AT THE FACILITY AND CONFIRMED THAT NO ONE IS PUSHING HARD ON THE FLOW SENSOR AND ALL ARE BEING EXTRA CAREFUL WITH THE CONNECTION; HOWEVER, THE WYE CONNECTORS CONTINUE TO CRACK. IT WAS ADVISED NONE OF THE CRACKED CIRCUITS WERE USED ON PATIENTS, THIS WAS FOUND DURING WEEKLY CHECKS PRIOR TO PATIENT USE. THE DEPARTMENT REPORTING THE ISSUE IS A LEVEL 2 NURSERY. ACCORDING TO THE CUSTOMER, VERY FEW INFANT PATIENTS ARE ADMITTED THAT NEED VENTILATION AT THIS FACILITY.  THIS IS WHY THE DEPARTMENT DECIDED TO START CHECKING THE VENTILATION SETUPS TO ENSURE EVERYTHING WAS READY IF A CRITICAL PATIENT WERE TO ARRIVE. THE CUSTOMER ADVISED CRACKS WERE FOUND ON 10 CIRCUITS. MOST OF THE CRACKED CIRCUITS HAVE BEEN DISCARDED, HOWEVER, THE CUSTOMER STATED ONE MAY BE AVAILABLE FOR EVALUATION. SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. IT HAS BEEN REQUESTED THAT IF THE CUSTOMER HAS A SAMPLE AVAILABLE THAT IT BE RETURNED TO CAREFUSION FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT RESP CIRC UNHTD 4FT HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER BZE CAREFUSION 4914-503 Y5L1318

    Patients

    Seq Age Sex Outcome Treatment
    1