BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 6295331 · Received February 1, 2017

    Report

    Report Number
    9611451-2017-00054
    Event Type
    Malfunction
    Date Received
    February 1, 2017
    Date of Event
    December 27, 2016
    Report Date
    January 4, 2017
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) THE RT205 ADULT INSPIRATORY HEATED 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 K983112. MANUFACTURER NARRATIVE METHOD: THE COMPLAINT RT205 ADULT INSPIRATORY HEATED BREATHING CIRCUIT (WITH UNKNOWN LOT NUMBER) AND THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER (LOT NUMBER 150918) WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE RETURNED DEVICES WERE VISUALLY INSPECTED. THE RT205 ADULT BREATHING CIRCUIT WAS ALSO PRESSURE TESTED FOR LEAKS. THE MR290 CHAMBER IS INCLUDED IN THE RT205 ADULT BREATHING CIRCUIT KIT. RESULTS: NO FAULT WAS FOUND WITH THE RT205 ADULT BREATHING CIRCUIT. THE PRESSURE TEST RESULT WAS WITHIN SPECIFICATION. VISUAL INSPECTION OF THE RETURNED MR290 CHAMBER REVEALED THAT THERE WAS A BREAK IN THE FEEDSET TUBING AT THE CONNECTION TO THE WATER BAG SPIKE. THE SURFACE AT THE BREAK WAS ROUGH (NOT SMOOTHLY CUT). CONCLUSION: THE DAMAGE ON THE FEEDSET TUBING APPEARED TO BE CAUSED BY THE TUBE BEING PULLED AWAY FROM THE SPIKE, POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR UNDER TENSION. THE LEAK REPORTED BY THE HOSPITAL WAS LIKELY DUE TO THE BREAK IN THE FEEDSET TUBING. ALL RT205 ADULT BREATHING CIRCUITS AND MR290 CHAMBERS ARE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS BEFORE BEING RELEASED FOR DISTRIBUTION. THOSE THAT FAIL ARE REJECTED. THE SUBJECT RT205 ADULT BREATHING CIRCUIT AND MR290 CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT205 ADULT BREATHING CIRCUIT AND THE MR290 CHAMBER STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS." THE USER INSTRUCTIONS OF THE RT205 ADULT BREATHING CIRCUIT ALSO REMIND THE USER TO "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE".

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): THE RT205 ADULT INSPIRATORY HEATED 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 K983112. MANUFACTURER NARRATIVE THE COMPLAINT RT205 ADULT INSPIRATORY HEATED BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION TO DETERMINE IF IT HAD A MALFUNCTION, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN RT205 ADULT INSPIRATORY HEATED BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT205 ADULT INSPIRATORY HEATED BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77638 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT205 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1