BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2122551 · Received June 13, 2011

    Report

    Report Number
    9611451-2011-00352
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 19, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE SWIVEL Y-PIECE OF THE RT125 INFANT BREATHING CIRCUIT WAS RETURNED TO FPH (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED FOR CRACK AND PRESSURE TESTED FOR LEAKS. RESULTS: VISUAL INSPECTION REVEALED THAT THE RETURNED SWIVEL Y-PIECE HAD A CRACK ON THE PORTS WHERE THE BREATHING CIRCUITS ARE CONNECTED. THE PRESSURE TEST RESULT WAS WITHIN THE REQUIRED SPECIFICATION. A LOT CHECK WAS NOT PERFORMED AS NO LOT INFORMATION HAD BEEN PROVIDED. CONCLUSION: ALL BREATHING CIRCUITS, INCLUDING THE SWIVELS, ARE VISUALLY INSPECTED AND PRESSURE TESTED BEFORE THEY ARE ALLOWED TO LEAVE THE PRODUCT LINE. THE AFFECTED SWIVEL Y-PIECE WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THIS SUGGESTS THE CRACK DEVELOPED POST-PRODUCTION, POSSIBLY THE BREATHING CIRCUITS WERE CONNECTED TO OR REMOVED FROM THE SWIVEL FORCEFULLY. THE RT125 USER INSTRUCTIONS THAT ACCOMPANY THE DEVICE 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". "THIS PRODUCT IS INTENDED TO BE USED FOR A MAXIMUM OF 7 DAYS". (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL (FPH) THAT THE SWIVEL Y-PIECE OF AN RT125 INFANT BIAS FLOW BREATHING CIRCUIT HAD CRACKED AFTER (B)(6) OF USE. IT WAS ALSO REPORTED THAT AIR LEAKED FROM THE SWIVEL. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT125 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1