BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3248495 · Received July 25, 2013

    Report

    Report Number
    9611451-2013-00547
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 28, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT CHAMBER IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4) METHOD: THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE CHAMBER WAS ORIGINALLY REPORTED AS BEING FROM LOT 130129. WHEN WE RECEIVED THE CHAMBER IT WAS NOTED THAT THE ACTUAL LOT NUMBER WAS 121010. THE CHAMBER WAS VISUALLY INSPECTED AND CONNECTED TO A WATER BAG TO CHECK FOR LEAK. RESULTS: VISUAL INSPECTION REVEALED THAT THE FEEDSET TUBE WAS SLIGHTLY PULLED OUT OF THE BAG SPIKE. SUFFICIENT GLUE WAS FOUND AT THE SPIKE AND FEEDSET TUBE CONNECTION, INDICATING THAT THE SPIKE/FEEDSET TUBE CONNECTION SHOULD HAVE FORMED A TIGHT BOND. A LOT CHECK REVEALED NO SIMILAR COMPLAINTS FOR LOT 121010. CONCLUSION: THIS TYPE OF DAMAGE CAN BE CAUSED BY THE USER MANIPULATING THE FEEDSET TUBE BY PULLING ON THE TUBING ITSELF, RATHER THAN BY GRASPING THE SPIKE. WE HAVE CONDUCTED EXTENSIVE TESTING OF THE MR290 CHAMBER, WITH PARTICULAR EMPHASIS ON FEEDSET BREAKS. SIGNIFICANTLY WE HAVE NOT BEEN ABLE TO REPLICATE FAILURE OF THE FEEDSET TUBE IN ANY OF OUR TESTING. 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. ADDITIONALLY ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. CHAMBERS THAT FAIL ANY OF THESE TESTS ARE DISCARDED. THIS SUGGESTS THAT THE DAMAGE OCCURRED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR290 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 VIA OUR DISTRIBUTOR THAT WATER LEAKED FROM AN MR290V HUMIDIFICATION CHAMBER AFTER ABOUT ONE HOUR OF PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT WATER LEAKED FROM AN MR290V HUMIDIFICATION CHAMBER AFTER ABOUT ONE HOUR OF PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348957 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1210100105

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE RT202 BREATHING CIRCUIT| FISHER & PAYKEL HEALTHCARE RT202 BREATHING CIRCUIT