BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    MDR report key: 5075846 · Received September 14, 2015

    Report

    Report Number
    9611451-2015-00405
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    August 18, 2015
    Report Date
    August 18, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: 150330, 150331. MANUFACTURING DATE: 03/30/2015, 03/31/2015. QUANTITY AFFECTED: 10, 10. METHOD: TWO RESERVE SAMPLES (ONE EACH FROM THE ABOVE LOT NUMBERS) WERE TURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: NO FAULT WAS FOUND WITH ANY OF THE RETURNED PRESSURE LINES AND BREATHING CIRCUITS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR BOTH LOT NUMBERS. CONCLUSION: ALTHOUGH RESERVE SAMPLES FROM THE AFFECTED LOTS WERE RETURNED, WE ARE STILL UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAULT AS THE PRESSURE LINE HAS TO BE CONNECTED DIRECTLY TO THE VENTILATOR AND FLOW GENERATOR. ALL INFANT BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED AND THOSE THAT FAIL ARE REJECTED. THE AFFECTED INFANT BREATHING CIRCUITS WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND PROPER USE OF THE (B)(4) INFANT CONTINUOUS FLOW BREATHING CIRCUIT AND 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 ALARM."

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: MANUFACTURING DATE: QUANTITY AFFECTED: 150330, 03/30/2015, (B)(4). 150331, 03/31/2015, (B)(4). THE COMPLAINT RT324 INFANT CONTINUOUS FLOW BREATHING CIRCUITS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(4) REPORTED THAT THE PRESSURE LINES OF 20 (B)(4) INFANT CONTINUOUS FLOW BREATHING CIRCUITS WOULD NOT STAY CONNECTED TO A SIPAP VENTILATOR. THIS WAS OBSERVED BEFORE USE ON PATIENTS.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT THE PRESSURE LINES OF 20 RT324 INFANT CONTINUOUS FLOW BREATHING CIRCUITS WOULD NOT STAY CONNECTED TO A SIPAP VENTILATOR. THIS WAS OBSERVED BEFORE USE ON PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605058 INFANT CONTINUOUS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT324 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1