BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3203620 · Received July 3, 2013

    Report

    Report Number
    9611451-2013-00505
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 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 CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS CONNECTED TO A WATER BAG TO TEST FOR THE REPORTED LEAK. RESULTS: WHEN THE RETURNED WATER FEEDSET TUBE WAS CONNECTED TO A WATER BAG AND PLACED UNDER TENSION A SMALL DROP OF WATER BEGAN TO BUILD AT THE FEEDSET TUBE AND WATERBAG SPIKE CONNECTION. A SUFFICIENT AMOUNT OF GLUE WAS IDENTIFIED AT THE SPIKE TUBING CONNECTION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 120614. CONCLUSION: THE REPORTED WATER LEAK WAS MOST LIKELY DUE TO THE WATER FEEDSET TUBE BEING SET UP UNDER TENSION. 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. TESTING INVOLVING SIMULATED AGEING OF THE FEEDSET TO CHECK WHETHER THE STRENGTH OF THE GLUE JOINT DECREASES OVER TIME REVEALED THAT THE FEEDSETS ON AGED CHAMBERS WERE ONLY BREAKING AT 50 TO 55N OR MORE, PROVING THAT SHELF LIFE HAS NO NEGATIVE IMPACT ON THE ULTIMATE TENSILE STRENGTH OF THE GLUE JOINT. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. THIS SUGGESTS THAT THE RETURNED FEEDSET TUBE ONLY STARTED TO LEAK AFTER IT 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."

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306583 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120614

    Patients

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