BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3590377 · Received January 23, 2014

    Report

    Report Number
    9611451-2014-00074
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    December 8, 2013
    Report Date
    December 26, 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). METHOD: THE COMPLAINT MR290 CHAMBERS (LOT 130719, 2X LOT 130802, & LOT 130801) WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4). THE COMPLAINT DEVICES WERE VISUALLY INSPECTED AND CONNECTED TO A WATER BAG TO TEST PERFORMANCE. RESULTS: THE VISUAL INSPECTION REVEALED THERE WAS SUFFICIENT GLUE AT THE WATER BAG SPIKE AND FEEDSET CONNECTION OF THE THREE CHAMBERS. HOWEVER, THE GLUE HAD ONLY PARTLY BONDED. FURTHERMORE, THE TUBE WAS FOUND TO BE SLIGHTLY PULLED OUT OF THE SPIKE. THE PERFORMANCE TEST SHOWED A WATER DROPLET HAD FORMED AT THE CONNECTION BETWEEN THE SPIKE AND THE FEEDSET TUBE. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR THE THREE LOT NUMBERS PROVIDED. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED FAULT, ALTHOUGH PAST INVESTIGATIONS HAVE SHOWN THAT THE 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 (B)(4) 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 PROBLEM OCCURRED AFTER THE PRODUCT 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 OF LOOSE WATER BAG SPIKES ON MR290 FEEDSETS HAS A RATE OF OCCURRENCE OF (B)(4) DEVICES PER (B)(4) SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF (B)(4) 2013.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT A LEAK OCCURRED BETWEEN THE MR290 AUTOFEED HUMIDIFICATION CHAMBER WATER FEEDSET TUBE AND THE WATER BAG SPIKE OF FOUR MR290 CHAMBERS AFTER ONE WEEK OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55564 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 130719

    Patients

    Seq Age Sex Outcome Treatment
    1