BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3120867 · Received May 20, 2013

    Report

    Report Number
    9611451-2013-00406
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 24, 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 CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND VISUALLY INSPECTED. RESULTS: THE WATER FEEDSET TUBE WAS SEPARATED FROM THE BAG SPIKE. VISUAL INSPECTION IDENTIFIED SUFFICIENT GLUE WAS PRESENT AROUND THE SPIKE TUBING CONNECTION; HOWEVER THE GLUE HAD NOT BONDED PROPERLY. A LOT CHECK REVEALED ONE OTHER SIMILAR COMPLAINT FOR LOT 120514. 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. THIS SUGGESTS THAT THE FAILURE OF THE BOND DEVELOPED AFTER RELEASE 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." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT WATER LEAKED FROM THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND BAG SPIKE OF AN MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBER AFTER 2 DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222042 VENTED AUTOFEED CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120514

    Patients

    Seq Age Sex Outcome Treatment
    1