BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3290566 · Received August 15, 2013

    Report

    Report Number
    9611451-2013-00599
    Event Type
    Malfunction
    Date Received
    August 15, 2013
    Date of Event
    July 17, 2013
    Report Date
    July 19, 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). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS FROM THE DISTRIBUTOR. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE RECEIVED THE COMPLAINT DEVICE AND COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4) LOT NUMBER:120731, MANUFACTURING DATE: 07/31/2012, QUANTITY AFFECTED: 1. THE 120907, ON 09/07/2012, 1. METHOD: THE TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THERE WAS A BREAK IN THE FEEDSET TUBINGS AT THE CONNECTION TO THE CHAMBERS. THE SURFACE OF THE BREAK WAS ROUGH (NOT SMOOTHLY CUT). A LOT CHECK REVEALED SIX OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120731 AND NO OTHER COMPLAINTS FOR LOT NUMBER 120907. CONCLUSION: THE DAMAGE APPEARED TO BE CAUSED BY THE TUBED BEING PULLED AWAY FROM THE CHAMBER, POSSIBLY DUE TO THE FEEDSETD BEING CAUGHT OR UNDER TENSION. THIS IS EVIDENCED BY THE ROUGH BREAK. 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 DAMAGE OCCURRED AFTER THE SUBJECT MR290 WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER 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 OUR DISTRIBUTOR THAT TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS EACH HAD A BROKEN WATER FEEDSET TUBE. THIS WAS OBSERVED WHEN THE RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS BAGS, CONTAINING THE SUBJECT MR290 CHAMBERS, WERE OPENED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO OUR DISTRIBUTOR THAT TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS EACH HAD A BROKEN WATER FEEDSET TUBE. THIS WAS OBSERVED WHEN THE RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS BAGS, WHICH CONTAINED THE SUBJECT MR290 CHAMBERS, WERE OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395751 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT