BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRLIFE¿ ISOTHERMAL BREATHING CIRCUIT 1.3 M (4.5') ¿ INFANT RESPIRATORY CIRCUIT

    MDR report key: 15831528 · Received November 20, 2022

    Report

    Report Number
    8030673-2022-00280
    Event Type
    Injury
    Date Received
    November 20, 2022
    Date of Event
    June 1, 2022
    Report Date
    November 20, 2022
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    BZE
    UDI-DI
    10190752157408
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE CUSTOMER CHANGED THE CIRCUIT TO PREVENT PATIENT INJURY/HARM. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION:THE DEVICE HISTORY RECORD OF THE FG INFANT RESP CIRC 4 FT PART NUMBER 6800-503 WITH LOT NUMBER 0004207263 AND THE DEVICE HISTORY RECORD OF THE PART NUMBER FLOAT STYLE WATER TRAP PART NUMBER 3185 WITH LOT NUMBER 1306333 WERE REVIEWED, AND NO ISSUES WERE FOUND. A CLOSED PHYSICAL SAMPLE WAS RECEIVED OF THE FG INFANT RESP CIRC 4 FT WITH LOT NUMBER 0004207263 WAS VISUALLY INSPECTED WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND ON THE SAMPLE RECIVED. MATERIAL MAY BE INVOLVED IN THE DEFECT. WE FOUND OUT THAT THE TANK, FLOAT WATER TRAP PART NUMBER 65-2054A, AND BODY, FLOAT WATER TRAP PART NUMBER 65-2011A, ARE DIFFICULT TO DISASSEMBLE. A QUALITY NOTIFICATION (QN-2023-006) WAS SENT TO THE SUPPLIER OF BOTH COMPONENTS FOR FURTHER INVESTIGATION. IN ADDITION, MANUFACTURING PERSONNEL MAY BE RELATED TO THE REPORTED DEFECT BECAUSE THE ASSEMBLY BETWEEN PARTS 65-2054A AND 65-2011A IS PERFORMED MANUALLY. IF MANUFACTURING PERSONNEL ASSEMBLY IS TOO HARD, A DEFECT LIKE THE ONE REPORTED IN THIS COMPLAINT COULD OCCUR. IN THE VIDEO RECEIVED, WE COULD OBSERVE THE CUSTOMER TRYING TO DISASSEMBLY THE WATER TRAP WITH CIRCULAR MOVEMENTS AS IF IT WERE THREADED, BUT WE RECOMMEND DISASSEMBLY PERFORMING MOVEMENTS SIDE TO SIDE TO SEPARATE THE TANK FLOAT WATER TRAP PART NUMBER 65-2054A FROM THE BODY FLOAT WATER TRAP PART NUMBER 65-2011A. ADDITIONALLY, IT WAS REVIEWED TO SEE IF THERE WERE PREVIOUS REPORTS IN THE LAST 3 YEARS RELATED TO THE DEFECT IN THIS COMPLAINT. NO TREND WAS FOUND. THE ROOT CAUSE WAS NOT DETERMINED. HOWEVER, VYAIRE WILL CONTINUE TO MONITOR AND FOLLOW UP ON THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE WATER TRAP WAS DIFFICULT TO REMOVE FROM THE 6800-503 CIRCUIT RESP INFANT 4FT UNHTD 30/CS. THE EVENT OCCURRED DURING USE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615183 AIRLIFE¿ ISOTHERMAL BREATHING CIRCUIT 1.3 M (4.5') ¿ INFANT RESPIRATORY CIRCUIT VENTILATOR BREATHING CIRCUIT, SINGLE-USE BZE VYAIRE MEDICAL CIRCUIT RESP INFANT 4FT UNHTD 30/CS 0004207263 10190752157408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention