BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANES CIRCUIT, ADULT, 72 IN CORR, 3L BAG

    MDR report key: 5814713 · Received July 21, 2016

    Report

    Report Number
    8030673-2016-00185
    Event Type
    Malfunction
    Date Received
    July 21, 2016
    Date of Event
    June 23, 2016
    Report Date
    October 24, 2016
    Manufacturer
    CAREFUSION/BD
    Product Code
    CAI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN CONFIRMED THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR EVALUATION. ATTEMPTS HAVE BEEN MADE BY CAREFUSION/BD TO GAIN ADDITIONAL INFORMATION FROM THE CUSTOMER AND END USER REGARDING SITUATION REPORTED WITH DEVICE. CAREFUSION/BD IS STILL WAITING FOR ADDITIONAL INFORMATION REGARDING REPORTED ISSUE. IF A SAMPLE OR ANY ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP EMDR WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, NO SAMPLE WAS AVAILABLE FOR INVESTIGATION; BECAUSE OF THIS WE COULD NOT CONFIRM THE FAILURE MODE. CAREFUSION/BD REVIEWED THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER AND NO ISSUES WERE FOUND. CAREFUSION/BD REVIEWED THE MANUFACTURING PROCEDURE FOR CORRECTNESS AND TO EVALUATE FOR ANY PROCESS IMPROVEMENTS. THE ULTRASONIC WELDING MACHINES (USW) PUSH BUTTONS SHOULD BE PRESSED TO ACTIVE USW. THE MANUFACTURING PROCEDURE SPECIFIES THAT THE MANUFACTURING PERSONNEL SHOULD KEEP THE USW PUSH BUTTONS PRESSED UNTIL THE WELDING CYCLE IS COMPLETED. CAREFUSION/BD SAW A NEED TO IMPROVE THIS PROCESS. A SENSOR HAS BEEN ADDED TO ELIMINATE THE POSSIBILITY OF HUMAN ERROR. THIS SENSOR ACTIVATES AN AUTOMATIC CONTROL; TO FINISH THE WELDING PROCESS. THIS STOPS THE OPERATOR ERROR OF REMOVING THE HANDS BEFORE THE CYCLE IS COMPLETED. CAREFUSION/BD HAS ENHANCED THE CONTROLS TO ALERT PERSONNEL WHEN THE WELDING CYCLE HAS NOT COMPLETED. IF A WELDING CYCLE IS NOT COMPLETED THE PRODUCT SHOULD BE SEGREGATED BY THE MANUFACTURING STAFF. WE HAVE OPENED A CORRECTIVE AND PREVENTATIVE ACTION PLAN TO CONTINUE TO INVESTIGATE AND IMPROVE ON THIS PROCESS. CAREFUSION/BD WILL ALSO CONTINUE TO TAKE AND TREND FOR THIS REPORTED FAILURE MODE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A CIRCUIT HME BROKE IN HALF DURING A THORACIC CASE. THE CIRCUIT WAS BEING USED ON A PATIENT WHEN IT FAILED. NO PATIENT HARM WAS REPORTED. THE AFFECTED SAMPLE IS UNVIABLE THE END-USER BELIEVES IT WAS DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466003 ANES CIRCUIT, ADULT, 72 IN CORR, 3L BAG CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI CAREFUSION/BD 0000942703

    Patients

    Seq Age Sex Outcome Treatment
    1