BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3686288 · Received March 18, 2014

    Report

    Report Number
    9611451-2014-00239
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    January 18, 2014
    Report Date
    February 17, 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) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THERE WAS A BREAK IN THE WATER FEEDSET TUBE AT THE POINT OF INSERTION TO THE WATER BAG SPIKE. THE SURFACE AT THE BREAK WAS ROUGH (NOT SMOOTHLY CUT). A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130624. CONCLUSION: THE DAMAGE APPEARS TO 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 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 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. THE CUSTOMER HAS CONFIRMED THAT THE SUBJECT MR290V CHAMBER WAS IN USE FOR TWO WEEKS BEFORE A WATER LEAK WAS OBSERVED, WHICH INDICATES THAT THE CHAMBER FEEDSET BECAME DAMAGED DURING USE. THE MR290 WAS USED IN CONJUNCTION WITH A FISHER & PAYKEL HEALTHCARE RT340 BREATHING CIRCUIT WHICH USER INSTRUCTIONS STATE: "THIS PRODUCT IS INTENDED TO BE USED FOR A MAXIMUM OF 7 DAYS." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS." OUR MONITORING AND TRENDING OF COMPLAINTS INVOLVING BROKEN OR DAMAGED WATER FEEDSET TUBES IN THE MR290 CHAMBERS HAS A RATE OF OCCURRENCE OF (B)(6) DEVICES PER (B)(6) SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF FEBRUARY 2014.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS LEAKING DURING USE. THIS OCCURRED AFTER TWO WEEKS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158705 VENTED AUTOFEED CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 130624

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE RT340 BREATHING CIRCUIT