BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3498572 · Received December 3, 2013

    Report

    Report Number
    9611451-2013-00964
    Event Type
    Malfunction
    Date Received
    December 3, 2013
    Date of Event
    October 31, 2013
    Report Date
    November 6, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FPH IN (B)(4) AND WAS VISUALLY INSPECTED. OUR INVESTIGATION IS ALSO BASED ON OUR PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS. RESULTS: THE SPIKE WAS FOUND DETACHED FROM THE WATER FEEDSET TUBE. FURTHER INSPECTION REVEALED THAT SUFFICIENT AMOUNT OF GLUE WAS PRESENT AROUND THE SPIKE TUBING CONNECTION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130704. CONCLUSION: WE WERE UNABLE TO DETERMINE DEFINITIVELY THE ROOT CAUSE OF THE REPORTED FAULT; HOWEVER, IT IS POSSIBLE THAT THE LEAKS FROM THE FEEDSET TUBES WERE DUE TO THE FAILURE OF THE GLUE BOND THAT JOINS THE SPIKES TO THE WATER FEEDSET TUBES. OUR PREVIOUS INVESTIGATION ON SIMILAR COMPLAINTS HAVE ALSO SHOWN THAT SUCH 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. (B)(4). 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 AUTOFEED HUMIDIFICATION CHAMBERS STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARM." "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 DISTRIBUTOR THAT THE WATER FEEDSET TUBE OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS FOUND LEAKING DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625658 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 130704

    Patients

    Seq Age Sex Outcome Treatment
    1 RT200 ADULT DUAL HEATED BREATHING CIRCUIT