BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3986082 · Received August 6, 2014

    Report

    Report Number
    9611451-2014-00674
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 8, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBERS (3 X LOT 130803, 2 X LOT 130823 & 2 X LOT 130920) WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4). THEREFORE, OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL AND OUR KNOWLEDGE OF THE PRODUCT. THE HOSPITAL REPORTED THAT THE MR290 CHAMBER WATER FEEDSETS WERE LEAKING AT THE CONNECTION TO THE WATER BAG SPIKE. WITHOUT THE RETURN OF THE COMPLAINT DEVICES, WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM EXPERIENCED BY THE CUSTOMER. THIS TYPE OF DAMAGE CAN BE THE RESULT OF THE TUBE BEING PULLED AWAY FROM THE SPIKE, POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR UNDER TENSION. PAST INVESTIGATIONS HAVE SHOWN THAT THIS IS 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 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." - "THIS PRODUCT IS INTENDED FOR USE FOR A MAXIMUM OF 7 DAYS."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE FEEDSETS OF SEVEN MR290 HUMIDIFICATION CHAMBERS WERE LEAKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460702 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 130803

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL RT380 BREATHING CIRCUIT