BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1971320 · Received January 26, 2011

    Report

    Report Number
    9611451-2011-00045
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 6, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE IN (B)(4), HOWEVER, THE DEVICE WAS DISPOSED OF AS THE DISTRIBUTOR ADVISED THAT THE CHAMBER PRESENTED A RISK OF INFECTION. METHOD: AN INVESTIGATION WAS CARRIED OUT BASED ON EVALUATION OF A CHAMBER THAT HAD BEEN RETURNED BY A HOSPITAL IN (B)(6) IN (B)(6) 2010, AS THE REPORTED FAULT IS SIMILAR. THE PREVIOUS COMPLAINT WAS REPORTED TO THE FDA UNDER MANUFACTURER REPORT NUMBER 9611451-2010-00789. RESULTS: IT WAS REPORTED TO FISHER & PAYKEL HEALTHCARE THAT AN MR290 CHAMBER WAS LEAKING FROM THE WATER FEEDSET. A LOT CHECK REVEALED TWO SIMILAR COMPLAINTS RELATING TO EIGHTEEN COMPLAINT DEVICES WITH LOT NUMBER 100213. THE SIMILAR COMPLAINTS WERE REPORTED BY A SINGLE HOSPITAL IN (B)(6) (MANUFACTURER REPORT NUMBERS 9611451-2010-00789 AND 9611451-2011-00036). CONCLUSION: BASED ON OUR PREVIOUS INVESTIGATION, IT IS POSSIBLE THAT THERE WAS INSUFFICIENT GLUE APPLIED BETWEEN THE CONNECTION OF THE FEEDSET SPIKE AND THE FEEDSET TUBE OF THE COMPLAINT CHAMBERS, RESULTING IN THE DEVELOPMENT OF A LEAK. 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 LEAK DEVELOPED POST PRODUCTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTION TO A PATIENT." AS PART OF OUR ONGOING IMPROVEMENT INITIATIVES, ADDITIONAL GLUE IS NOW APPLIED TO THE FEEDSET SPIKE DURING PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN MR290 AUTOFEED HUMIDIFICATION CHAMBER LEAKED FROM THE WATERFEED TUBING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 100213

    Patients

    Seq Age Sex Outcome Treatment
    1