BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3304441 · Received August 22, 2013

    Report

    Report Number
    9611451-2013-00628
    Event Type
    Malfunction
    Date Received
    August 22, 2013
    Date of Event
    July 25, 2013
    Report Date
    July 26, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE TWO COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE TWO CHAMBERS REVEALED THAT THERE WAS A BREAK IN THE FEEDSET TUBING AT THE CONNECTION TO THE SPIKE. THE SURFACE OF THE BREAK WAS ROUGH (NOT SMOOTHLY CUT) FOR BOTH CHAMBER FEEDSET TUBES. A LOT CHECK FOR DEVICE 1, LOT DATE 121129, REVEALED NO OTHER COMPLAINTS. DEVICE 2, LOT DATE 120822, REVEALED (B)(4) COMPLAINT OF A SIMILAR NATURE. CONCLUSION: THE DAMAGE APPEARED TO BE CAUSED BY THE TUBE BEING PULLED AWAY FROM THE CHAMBER, POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR UNDER TENSION. THIS IS EVIDENCED BY THE ROUGH BREAK. 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. 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 SUBJECT MR290 WAS RELEASED 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." OUR MONITORING AND TRENDING OF COMPLAINTS INVOLVING BROKEN OR DAMAGED WATER FEEDSET TUBES IN MR290 CHAMBERS HAS A RATE OF OCCURRENCE OF (B)(4) WORLDWIDE IN THE LAST YEAR TO THE END OF AUGUST 2013.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS CURRENTLY ENROUTE TO FISHER & PAYKEL HEALTHCARE, (B)(4). WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO OUR DISTRIBUTOR THAT TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS HAD BROKEN WATERFEEDSET TUBES. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO OUR DISTRIBUTOR THAT TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS HAD BROKEN WATER FEEDSET TUBES. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407983 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 121129

    Patients

    Seq Age Sex Outcome Treatment
    1 RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT| RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUIT| RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUIT| RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT