BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3163372 · Received June 11, 2013

    Report

    Report Number
    9611451-2013-00441
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 7, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURER DATE: DEVICE 1 - LOT 120627 - 06/27/2012; DEVICE 2 - LOT 100312 - 03/12/2010. METHOD: THE TWO COMPLAINT CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. THE COMPLAINT CHAMBERS WERE VISUALLY INSPECTED AND CONNECTED TO A WATERBAG TO TEST FOR LEAKS. RESULTS: DEVICE 1, MR290V CHAMBER LOT 120627: THE VISUAL INSPECTION IDENTIFIED THAT THE FEEDSET TUBE OF THE COMPLAINT CHAMBER TO BE PULLED SLIGHTLY OUT OF THE WATERBAG SPIKE. SMALL DROPS OF WATER BEGAN TO BUILD AT THE CONNECTION BETWEEN THE FEEDSET TUBE AND THE WATERBAG SPIKE WHEN THE COMPLAINT CHAMBER WAS CONNECTED TO A WATER BAG. A SUFFICIENT AMOUNT OF GLUE WAS PRESENT AROUND THE SPIKE TUBING CONNECTION. DEVICE 2, MR290V CHAMBER LOT 100312: NO VISIBLE DAMAGE WAS OBSERVED ON THE COMPLAINT CHAMBER WITH LOT 100312. WHEN THE WATER FEEDSET TUBE OF THE COMPLAINT CHAMBER WAS PLACED UNDER TENSION SMALL DROPS OF WATER BEGAN TO BUILD UP AT THE CONNECTION BETWEEN THE FEEDSET TUBE AND WATERBAG SPIKE. A SUFFICIENT AMOUNT OF GLUE WAS PRESENT AROUND THE SPIKE TUBING CONNECTION. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS OF THIS NATURE FOR LOT 120627 AND LOT 100312. CONCLUSION: IT IS MOST LIKELY THAT THE FEEDSET WAS SET UP UNDER TENSION, CAUSING THE OBSERVED WATER LEAKAGE. WE HAVE CONDUCTED EXTENSIVE TESTING OF OUR MR290 CHAMBER, WITH PARTICULAR EMPHASIS ON FEEDSET BREAKS. 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. TESTING INVOLVING SIMULATED AGEING OF THE FEEDSET TO CHECK WHETHER THE STRENGTH OF THE GLUE JOINT DECREASES OVER TIME REVEALED THAT THE FEEDSETS ON AGED CHAMBERS WERE ONLY BREAKING AT 50 TO 55N OR MORE, PROVING THAT SHELF LIFE HAS NO NEGATIVE IMPACT ON THE ULTIMATE TENSILE STRENGTH OF THE GLUE JOINT. 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 DAMAGE TO THE FEEDSET TUBE OCCURRED AFTER RELEASE 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT WATER LEAKED FROM THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND BAG SPIKE OF TWO MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBERS DURING SET UP. THIS WAS REPORTED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264036 VENTED AUTOFEED CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 100312, 120627

    Patients

    Seq Age Sex Outcome Treatment
    1 RT200 ADULT DUAL-HEATED BREATHING CIRCUIT