BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT LOW FLOW BREATHING CIRCUIT

    MDR report key: 2775180 · Received October 7, 2012

    Report

    Report Number
    9611451-2012-00715
    Event Type
    Malfunction
    Date Received
    October 7, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 10, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: 120315, 120430; MANUFACTURING DATE: 03/15/2012, 04/30/2012; QUANTITY AFFECTED: (B)(4). THE RT226 INFANT LOW FLOW BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. THE COMPLAINT BREATHING CIRCUITS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4).LOT NUMBER MANUFACTURING DATE QUANTITY AFFECTED120315 03/15/2012 1 120430 04/30/2012 1 THE RT226 INFANT LOW FLOW BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332.METHOD: TWO COMPLAINT RT226 INFANT LOW FLOW BREATHING CIRCUITS WITH LOT NUMBERS 120315 AND 120430 WERE RETURNED TO FPH IN (B)(4) IN UNSEALED BAGS. THE RETURNED BREATHING CIRCUITS WERE PRESSURE TESTED AND IMMERSED IN A WATER BATH TO TEST FOR LEAKS.RESULTS: THE PRESSURE TEST RESULT OF THE BREATHING CIRCUIT WITH LOT NUMBER 120315 WAS OUTSIDE THE REQUIRED SPECIFICATION. UPON IMMERSION IN A WATER BATH, A LEAK WAS DETECTED AT THE LUER PORT OF THE EXPIRATORY LIMB. NO FAULT WAS FOUND WITH THE BREATHING CIRCUIT WITH LOT NUMBER 120430. THE PRESSURE TEST RESULT WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR BOTH LOT NUMBERS. CONCLUSION: ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE REPORTED LEAKS DEVELOPED POST PRODUCTION.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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A DISTRIBUTOR THAT TWO RT226 INFANT LOW FLOW BREATHING CIRCUITS EACH HAD A "FAULTY FLOW SUPPLY". NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A DISTRIBUTOR THAT TWO RT226 INFANT LOW FLOW BREATHING CIRCUITS EACH HAD A "FAULTY FLOW SUPPLY". NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1