BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3633178 · Received February 18, 2014

    Report

    Report Number
    9611451-2014-00138
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    December 24, 2013
    Report Date
    January 30, 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 MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED AND CONNECTED TO A WATERBAG TO TEST FOR LEAKS. OUR INVESTIGATION IS ALSO BASED ON OUR PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS. RESULTS: SMALL DROPS OF WATER BEGAN TO BUILD UP AT THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND SPIKE. VISUAL INSPECTION REVEALED THAT SUFFICIENT AMOUNT OF GLUE WAS PRESENT AROUND THE SPIKE TUBING CONNECTION; HOWEVER, THE GLUE HAD ONLY PARTLY BONDED. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 121208. CONCLUSION: WE WERE UNABLE TO DETERMINE DEFINITIVELY THE ROOT CAUSE OF THE REPORTED FAULT; HOWEVER, IT IS POSSIBLE THAT THE LEAKS 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 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." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT WATER LEAKED AT THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND WATER BAG SPIKE OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102789 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 1212080105

    Patients

    Seq Age Sex Outcome Treatment
    1 RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT