BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 2843177 · Received November 21, 2012

    Report

    Report Number
    9611451-2012-00837
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 20, 2012
    Report Date
    October 24, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. METHOD: THE COMPLAINT RT205 BREATHING CIRCUITS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INSPECTION. THERE WERE TWO COMPLAINTS FROM LOT NUMBER 120316 AND TWO FROM LOT 120702. THE NURSE STATED THAT THE COMPLAINT CIRCUITS HAD BEEN THROWN AWAY. RESULTS: A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THE LOT NUMBERS PROVIDED. CONCLUSION: BASED ON OUR FINDINGS FROM INVESTIGATIONS INTO SIMILAR COMPLAINTS, IT IS POSSIBLE THAT THE DRYLINES HAD HOLES IN THEM. IT WAS IDENTIFIED THAT DAMAGE TO THE RT105 DRYLINE TUBE COULD HAVE BEEN CAUSED DURING THE MANUFACTURING PROCESS. DURING THE PRODUCTION OF THE DRYLINE TUBES, A PRESSURE TEST IS PERFORMED EVERY 10 TO 15 MINUTES AND THOSE THAT FAIL ARE SET ASIDE FOR FURTHER INSPECTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT105 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT 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." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) AND REPORTED THAT THREE RT205 ADULT BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST AND A FOURTH HAD LEAK DETECTED DURING SETUP; ALL FOUR HAD 'LEAKY' DRYLINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT205 120316

    Patients

    Seq Age Sex Outcome Treatment
    1