BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2186479 · Received August 1, 2011

    Report

    Report Number
    9611451-2011-00460
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Report Date
    July 7, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT225 INFANT BIAS FLOW BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER OF THAT PRODUCT IS K20332. THE COMPLAINT RT225 INFANT BREATHING CIRCUITS ARE NOT EXPECTEVE TO BE RETURNED TO FPH (B)(4) FOR INSPECTION. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING MORE INFORMATION REGARDING THIS COMPLAINT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT225 INFANT BIAS FLOW BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER OF THAT PRODUCT IS K20332. MANUFACTURER NARRATIVE: THE COMPLAINT RT225 INFANT BREATHING CIRCUIT IS NOT EXPECTED TO BE RETURNED TO FPH (B)(4) FOR INVESTIGATION. OUR ANALYSIS WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND INFORMATION PROVIDED BY THE HOSPITAL. THE HOSPITAL REPORTED THAT AN RT225 INFANT BREATHING CIRCUIT WOULD NOT FUNCTION WHEN USED ON HIGH FREQUENCY OSCILLATION WITH DRAGER BABYLOG 8000 VENTILATOR. THE VENTILATOR WAS SET UP TO A FREQUENCY OF 7HZ AND PRESSURE OF 23-25CMH2O. THE FLOW RATE USED WAS 8L/MIN. THE RT225 INFANT BREATHING CIRCUIT IS DESIGNED TO BE USED WITH THE DRAGER BABYLOG VENTILATOR, AND THE SETTINGS USED BY THE HOSPITAL APPEAR TO BE WITHIN THE ACCEPTABLE LIMITS FOR THIS BREATHING CIRCUIT. ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL REVEALED THAT THERE WERE "ERRORS ON SET-UP" AND THESE INCLUDES "THE PROBE BEING INSIDE THE INCUBATOR" AND "THE INCORRECT POSITIONING OF THE WATER TRAP". A LOT CHECK WAS NOT PERFORMED AS NO LOT INFORMATION HAD BEEN PROVIDED. ALL BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED PRIOR TO LEAVING THE PRODUCTION LINE TO CHECK FOR PHYSICAL DAMAGE AND LEAKS. ANY BREATHING CIRCUIT WHICH FAILS THESE TESTS IS REJECTED. THIS SUGGESTS THE AFFECTED RT225 INFANT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT225 INFANT BIAS 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." THIS IS THE ONLY COMPLAINT OF THIS NATURE THAT WE RECEIVED FOR THE RT225 INFANT BIAS FLOW BREATHING CIRCUIT IN THE PAST 12 MONTHS TO (B)(6) 2011. NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THREE RT225 INFANT BIAS FLOW BREATHING CIRCUITS WOULD NOT FUNCTION WHEN CONNECTED TO BABYLOG 8000 VENTILATOR. THIS WAS NOTICED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THREE RT225 INFANT BIAS FLOW BREATHING CIRCUITS WOULD NOT FUNCTION WHEN CONNECTED TO BABYLOG 8000 VENTILATOR. THIS WAS NOTICED DURING USE ON A PATIENT. NO PATIENT CONSEQUECE 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 RT225 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1