BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3892944 · Received June 24, 2014

    Report

    Report Number
    9611451-2014-00547
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 27, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO MR290V VENTED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE THEY WERE VISUALLY INSPECTED. ONE OF THE RETURNED CHAMBERS WAS FROM LOT 131210 AND THE OTHER FROM LOT 131218 (DATE OF MANUFACTURE 18 DECEMBER 2013). RESULTS: VISUAL INSPECTION REVEALED A BREAK IN THE WATER FEEDSET TUBE AT THE CONNECTION TO THE CHAMBER DOME ON BOTH OF THE RETURNED CHAMBERS. THE SURFACE OF THE BREAK ON BOTH OF THE TUBES WAS ROUGH (NOT SMOOTHLY CUT). A LOT CHECK REVEALED TWO OTHER COMPLAINTS OF THIS NATURE, ONE FROM LOT 131210 AND THE OTHER FROM LOT 131218. CONCLUSION: THE DAMAGE OBSERVED ON THE RETURNED MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WAS MOST LIKELY CAUSED BY THE FEEDSET TUBE BEING PULLED AWAY FROM THE CHAMBER, POSSIBLY DUE TO THE FEEDSET TUBE BEING CAUGHT OR UNDER TENSION. WE HAVE CONDUCTED EXTENSIVE TESTING OF THE MR290 CHAMBER, WITH PARTICULAR EMPHASIS ON FEEDSET BREAKS. SIGNIFICANTLY WE HAVE NOT BEEN ABLE TO REPLICATE FAILURE OF THE FEEDSET TUBE AT THE CHAMBER DOME IN ANY OF OUR TESTING. THE SPECIFICATION FOR THE CHAMBER REQUIRES THAT THE FEEDSET TUBE SHOULD HAVE A BREAKING STRAIN OF 30 NEWTONS. DURING PRODUCTION, PULL TESTING OF THE FEEDSET STRENGTH AT BOTH SPIKE AND DOME END IS PERFORMED EVERY HOUR ON MR290 CHAMBERS FROM EACH PRODUCTION LINE. ANY CHAMBER THAT FAILS IS REJECTED AND THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. ANY CHAMBER THAT FAILS IS REJECTED. THIS SUGGESTS THAT THE DAMAGE TO THE FEEDSET TUBE OCCURRED AFTER THE CHAMBERS WERE RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR290 STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARMS." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE LEAKING.NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367859 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 131210

    Patients

    Seq Age Sex Outcome Treatment
    1 RT340 ADULT BREATHING CIRCUIT