BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3870892 · Received June 12, 2014

    Report

    Report Number
    9611451-2014-00503
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 15, 2014
    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 COMPLAINT MR290 CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A BREAK IN THE FEEDSET TUBING AT THE CONNECTION TO THE CHAMBER DOME. THE SURFACE AT THE BREAK WAS ROUGH. THE DAMAGE APPEARED TO BE DUE TO THE TUBE BEING PULLED AWAY FROM THE CHAMBER, POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR PUT UNDER TENSION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 140303. CONCLUSION: WE WERE UNABLE TO DEFINITIVELY DETERMINE THE CAUSE OF THE FEEDSET BREAK, HOWEVER OUR PREVIOUS INVESTIGATIONS INTO SIMILAR COMPLAINTS HAVE SHOWN THAT THIS DAMAGE CAN BE CAUSED BY THE OVERSTRETCHING OF THE TUBING WHEN ATTACHING IT TO A WATER BAG. 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 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 DAMAGED WATER FEEDSETS IN MR290 CHAMBERS HAS A RATE OF OCCURRENCE OF 45 DEVICES PER MILLION SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF (B)(4) 2014.

    Description of Event or Problem · 1

    A MEDICAL CENTRE IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE WATER FEEDSET OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER STARTED TO LEAK AT THE CHAMBER DOME CONNECTION. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347012 VENTED AUTOFEED CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 140303

    Patients

    Seq Age Sex Outcome Treatment
    1