BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3223075 · Received July 12, 2013

    Report

    Report Number
    9611451-2013-00528
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 14, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. IT WAS VISUALLY INSPECTED AND CONECTED TO A WATER BAG. RESULTS: UPON CONNECTING THE RETURNED CHAMBER TO A WATER BAG, A SMALL DROP OF WATER BEGAN TO BUILD AT THE CONNECTION BETWEEN THE FEEDSET TUBE AND WATER BAG SPIKE. A SUFFICIENT AMOUNT OF GLUE WAS PRESENT AROUND THE SPIKE TUBING CONNECTION; HOWEVER THE GLUE HAD NOT BONDED PROPERLY. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 121214. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE LEAK OBSERVED ON THE RETURNED MR290V CHAMBER. 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 FAILURE OF THE BOND DEVELOPED AFTER THE CHAMBER WAS RELEASED FOR DISTRIBUTION. 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. 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 A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THE WATER FEEDSET TUBE ON AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS LEAKING FROM THE BAG SPIKE. THIS WAS FOUND DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323604 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 121214

    Patients

    Seq Age Sex Outcome Treatment
    1 FPH RT236 INFANT EVAQUA BREATHING CIRCUIT