BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3211709 · Received July 8, 2013

    Report

    Report Number
    9611451-2013-00519
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE TWO COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. ONE CHAMBER, DEVICE 1, WAS FROM LOT 120510, MANUFACTURED 10 MAY 2012, AND THE OTHER CHAMBER, DEVICE 2, WAS FROM LOT 120525, MANUFACTURED 25 MAY 2012. THE CHAMBERS WERE VISUALLY INSPECTED AND CONNECTED TO A WATER BAG TO CHECK FOR LEAK. RESULTS: VISUAL INSPECTION REVEALED THAT IN BOTH CHAMBERS THE FEEDSET TUBE WAS SLIGHTLY PULLED OUT OF THE BAG SPIKE. SUFFICIENT GLUE WAS FOUND AT THE SPIKE AND FEEDSET TUBE CONNECTION, INDICATING THAT THE SPIKE/FEEDSET TUBE CONNECTION SHOULD HAVE FORMED A TIGHT BOND. DEVICE 1 PASSED THE PERFORMANCE TEST, HOWEVER WHEN THE TEST WAS REPEATED WITH THE FEEDSET UNDER TENSION LEAKAGE OCCURRED FROM THE SPIKE/FEEDSET CONNECTION. LEAKAGE OCCURRED AT THE SPIKE/FEEDSET CONNECTION FROM DEVICE 2 DURING THE PERFORMANCE TEST. A LOT CHECK REVEALED NO SIMILAR COMPLAINTS FOR LOT 120510 AND ONE SIMILAR COMPLAINT FOR LOT 132890. CONCLUSION: THIS TYPE OF DAMAGE CAN BE CAUSED BY THE USER MANIPULATING THE FEEDSET TUBE BY PULLING ON THE TUBING ITSELF, RATHER THAN BY GRASPING THE SPIKE. 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 IN ANY OF OUR TESTING. (B)(4). 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. ADDITIONALLY ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. CHAMBERS THAT FAIL ANY OF THESE TESTS ARE DISCARDED. THIS SUGGESTS THAT THE DAMAGE OCCURRED AFTER THE PRODUCT WAS 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." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT WATER LEAKED AT THE CONNECTION OF THE BAG SPIKE AND THE WATER FEED TUBE OF TWO MR290V HUMIDIFICATION CHAMBERS JUST AFTER START OF USE. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308628 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120510

    Patients

    Seq Age Sex Outcome Treatment
    1