BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3483065 · Received November 22, 2013

    Report

    Report Number
    9611451-2013-00941
    Event Type
    Malfunction
    Date Received
    November 22, 2013
    Date of Event
    October 17, 2013
    Report Date
    October 23, 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 MR290V VENTED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED AND CONNECTED TO A WATER BAG TO TEST FOR LEAK. RESULTS: VISUAL INSPECTION REVEALED THAT THE FEEDSET TUBE WAS SLIGHTLY PULLED OUT OF THE BAG SPIKE. UPON CONNECTING THE RETURNED MR290V CHAMBER TO A WATER BAG, A DROP OF WATER BEGAN TO BUILD AT THE CONNECTION BETWEEN THE FEEDSET TUBE AND WATER BAG SPIKE. A SUFFICIENT AMOUNT OF GLUE WAS PRESENT AT THE FEEDSET TUBE AND BAG SPIKE CONNECTION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130328. CONCLUSION: THE DAMAGE OBSERVED ON THE RETURNED MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS MOST LIKELY CAUSED BY THE FEEDSET TUBE BEING SETUP IN 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 CHAMBER 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THEY FOUND A WATER LEAK FROM THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND THE BAG SPIKE ON AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER. THIS WAS FOUND AFTER 16 DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609175 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 130328

    Patients

    Seq Age Sex Outcome Treatment
    1