BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3453631 · Received November 6, 2013

    Report

    Report Number
    9611451-2013-00884
    Event Type
    Malfunction
    Date Received
    November 6, 2013
    Date of Event
    September 30, 2013
    Report Date
    October 8, 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 COMPLAINT MR290 CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND WAS VISUALLY INSPECTED AND PERFORMANCE TESTED BY CONNECTING IT TO A WATER BAG. RESULTS: INSPECTION OF THE COMPLAINT FEEDSET TUBE AND WATER BAG SPIKE REVEALED THAT THERE WAS SUFFICIENT GLUE ON THE FEEDSET TUBE BUT THE GLUE WAS ONLY PARTLY BONDING. DURING THE PERFORMANCE TEST A DROP OF WATER BEGAN TO BUILD AT THE CONNECTION BETWEEN THE FEEDSET TUBE AND THE WATER BAG SPIKE, CONFIRMING THE LOCATION OF THE LEAK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130624. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED FAULT, ALTHOUGH PAST INVESTIGATIONS HAVE SHOWN THAT THE PROBLEM HAS BEEN CAUSED BY THE USER REMOVING THE SPIKE BY GRASPING THE TUBING INSTEAD OF 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 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. 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 PROBLEM OCCURRED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER 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 TO A FISHER & PAYKEL FIELD REPRESENTATIVE THAT WATER LEAKED AT THE CONNECTION OF THE BAG SPIKE AND WATER FEED TUBE OF AN MR290 HUMIDIFICATION CHAMBER AT START OF USE. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572057 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1306240105

    Patients

    Seq Age Sex Outcome Treatment
    1