BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3834023 · Received May 27, 2014

    Report

    Report Number
    9611451-2014-00467
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 28, 2014
    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). METHOD: THE TWO COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBERS (1 X LOT 1310090105 & 1 X LOT 131210) WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A BREAK IN BOTH OF THE FEEDSET TUBINGS WHERE THEY CONNECT TO THE CHAMBER DOME.THE SURFACE AT THE BREAK WAS ROUGH (NOT SMOOTHLY CUT). A LOT CHECK REVEALED ONE OTHER SIMILAR COMPLAINT FOR LOT 1310090105 AND NO OTHER SIMILAR COMPLAINTS FOR LOT 131210. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT CAUSED THE REPORTED DAMAGE. HOWEVER THE DAMAGE APPEARS TO BE THE RESULT OF THE TUBE BEING PULLED AWAY FROM THE DOME, POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR UNDER TENSION. 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 AT THE CHAMBER DOME 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. IF ANY FAULTS ARE DETECTED THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. 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 PROBLEM OCCURRED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 AUTOFEED HUMIDIFICATION CHAMBERS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE PROVIDED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE FEEDSETS OF TWO MR290 HUMIDIFICATION CHAMBERS WERE LEAKING. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE FEEDSETS OF TWO MR290 HUMIDIFICATION CHAMBERS WERE LEAKING. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310983 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 131009

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL RT340 BREATHING CIRCUIT| FISHER & PAYKEL RT340 BREATHING CIRCUIT