BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT LOW FLOW BREATHING CIRCUIT

    MDR report key: 3911116 · Received July 2, 2014

    Report

    Report Number
    9611451-2014-00587
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 16, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT226 INFANT LOW FLOW BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE BREATHING CIRCUIT WAS VISUALLY INSPECTED, PRESSURE TESTED AND IMMERSED IN A WATER BATH. RESULTS: THE PRESSURE TEST RESULT FOR THE COMPLAINT BREATHING CIRCUIT WAS OUT OF SPECIFICATION DUE TO AN EXCESSIVE LEAK. WHEN THE BREATHING CIRCUIT WAS IMMERSED IN THE WATER BATH THE LEAK WAS OBSERVED AT THE SWIVEL ASSEMBLY. VISUAL INSPECTION REVEALED THAT THE SEALING AREA OF THE SWIVEL, BETWEEN THE ELBOW AND THE WYE, WAS DAMAGED. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT DATE 131023. CONCLUSION: BASED ON THE INSPECTION CONDUCTED, IT IS LIKELY THAT THE COMPLAINT BREATHING CIRCUIT MAY HAVE BEEN SUBJECTED TO A PHYSICAL FORCE SUFFICIENT ENOUGH TO DAMAGE THE SWIVEL WYE. ALL RT226 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS BEFORE RELEASING FOR DISTRIBUTION. ANY BREATHING CIRCUIT WHICH FAILS ANY OF THESE TESTS IS DISCARDED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT226 INFANT LOW FLOW BREATHING CIRCUIT STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS." HOSPITAL STAFF CORRECTLY CHECKED THE BREATHING CIRCUIT BEFORE PATIENT USE, WHICH IS IN LINE WITH OUR USER INSTRUCTIONS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN RT226 INFANT LOW FLOW BREATHING CIRCUIT FAILED THE PB840 VENTILATOR LEAK TEST. THIS OCCURRED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386193 INFANT LOW FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT226 131023

    Patients

    Seq Age Sex Outcome Treatment
    1