BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3304456 · Received August 22, 2013

    Report

    Report Number
    9611451-2013-00624
    Event Type
    Malfunction
    Date Received
    August 22, 2013
    Date of Event
    July 25, 2013
    Report Date
    July 26, 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). LOT DATES: - 120628; - 121122; - 121212. DEVICE MANUFACTURER DATE - LOT 120628 - 06/28/2012; - LOT 121122 - 11/22/2013; - LOT 121212 - 12/12/2012. METHOD: ONE COMPLAINT CHAMBER, LOT 121122, WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE SPIKE AND THE FEEDSET TUBING WERE SEPARATED FROM EACH OTHER. A SUFFICIENT AMOUNT OF GLUE WAS PRESENT AROUND THE SPIKE TUBING CONNECTION; HOWEVER THE GLUE HAD NOT BONDED PROPERLY. WITHOUT THE RETURN OF THE OTHER THREE REPORTED CHAMBERS, WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM OBSERVED BY THE CUSTOMER. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 121122. CONCLUSION: THE SEPARATION OF THE SPIKE AND FEEDSET TUBE WAS DUE TO THE FAILURE OF THE GLUE BOND. WE WERE UNABLE TO DETERMINE THE CAUSE FOR THIS. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. OUR HOURLY PROCESS MONITORING IDENTIFIED THAT THE FEEDSETS ON THE MR290 CHAMBERS BREAK AT 50-55N. THIS SUGGESTS THAT THE FAILURE OF THE BOND DEVELOPED AFTER THE CHAMBER 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 VIA OUR DISTRIBUTOR THAT WATER LEAKED FROM THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND BAG SPIKE OF FOUR MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBERS JUST AFTER USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407806 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290V SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 RT212 ADULT INSPIRATORY HEATED BREATHING CIRCUIT