BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3914494 · Received July 3, 2014

    Report

    Report Number
    9611451-2014-00598
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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). METHOD: THE COMPLAINT (B)(4) VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. RESULTS: INSPECTION OF THE COMPLAINT FEEDSET TUBE AND WATER BAG SPIKE REVEALED THAT THERE WAS SUFFICIENT GLUE ON THE CONNECTIONS BUT THE GLUE WAS ONLY PARTLY BONDING. DURING THE PERFORMANCE TEST, WATER DROPLETS FORMED AT THE CONNECTION BETWEEN THE SPIKE AND FEEDSET. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 140414. CONCLUSION: WE WERE UNABLE TO DETERMINE DEFINITIVELY THE ROOT CAUSE OF THE REPORTED FAULT; HOWEVER, IT IS POSSIBLE THAT THE LEAK FROM THE FEEDSET TUBE WAS DUE TO THE FAILURE OF THE GLUE BOND THAT JOINS THE SPIKE TO THE WATER FEEDSET TUBE. OUR PREVIOUS INVESTIGATION ON SIMILAR COMPLAINTS HAVE ALSO SHOWN THAT SUCH PROBLEM HAS BEEN CAUSED BY THE USER REMOVING THE SPIKE BY GRASPING THE TUBING INSTEAD OF 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 AT THE SPIKE 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. 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 LOOSE SPIKE CONNECTIONS IN THE MR290 FEEDSET TUBES HAS A RATE OF OCCURRENCE OF (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE WATER FEEDSET TUBE OF AN (B)(4) VENTED AUTOFEED HUMIDIFICATION CHAMBER LEAKED AT THE SPIKE WHEN CHECKED BEFORE USE. THIS OCCURRED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389547 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 140414

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE RT330 BREATHING CIRCUIT