BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3206972 · Received July 5, 2013

    Report

    Report Number
    9611451-2013-00507
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HEALTHCARE FACILITY HAS REPORTED TWO EVENT DATES (B)(6) 2013. LOT DATES OF RETURNED DEVICES: 120414 & 120531. RETURNED DEVICES: DEVICE 1: MR290V CHAMBER FROM LOT 120414 (DATE OF MANUFACTURE: 04/14/2012); DEVICE 2 & 3: MR290V CHAMBERS FROM LOT 120531 (DATE OF MANUFACTURE: 05/31/2012). METHOD: THREE MR290V CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(6) WHERE THEY WERE VISUALLY INSPECTED. DEVICES 2 & 3 WERE SUBSEQUENTLY CONNECTED TO A WATER BAG TO TEST FOR THE REPORTED LEAK. RESULTS: VISUAL INSPECTION OF DEVICE 1 REVEALED A TRIANGLE SHAPED CRACK ON THE SIDE OF THE CHAMBER DOME. NO STRESS MARKS WERE NOTED AROUND THE CRACK. UPON CONNECTING DEVICES 2 & 3 TO A WATER BAG, A SMALL WATER DROP STARTED TO BUILD AT THE WATER FEEDSET AND CHAMBER DOME CONNECTION ON BOTH OF THE CHAMBERS. FURTHER INSPECTION REVEALED A SMALL TEAR IN THE FEEDSET TUBE OF DEVICE 2 AND THE FEEDSET TUBE OF DEVICE 3 WAS FOUND TO BE SLIGHTLY PULLED OUT OF THE CHAMBER DOME. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120414 AND OTHER COMPLAINTS FOR LOT 120531. CONCLUSION: THE CRACK IDENTIFIED ON DEVICE 1 WAS MOST LIKELY CAUSED BY PHYSICAL IMPACT TO THE SIDE OF THE CHAMBER DOME. THE DAMAGE OBSERVED ON DEVICES 2 & 3 SUGGESTS THAT THE FEEDSET TUBE MAY HAVE BEEN PULLED AWAY FROM THE CHAMBER POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR UNDER TENSION. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS AND DISCARDED. THE SPECIFICATION FOR THE MR290V 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. THIS SUGGESTS THAT THE DAMAGE OBSERVED ON THE RETURNED CHAMBERS OCCURRED AFTER THEY WERE RELEASED FOR DISTRIBUTION. TESTING INVOLVING SIMULATED AGEING OF THE FEEDSET TO CHECK WHETHER THE STRENGTH OF THE GLUE JOINT DECREASES OVER TIME REVEALED THAT THE FEEDSETS ON AGED CHAMBERS WERE ONLY BREAKING AT 50 TO 55N OR MORE, PROVING THAT SHELF LIFE HAS NO NEGATIVE IMPACT ON THE ULTIMATE TENSILE STRENGTH OF THE GLUE JOINT. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR290 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." "DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT WHEN RECEIVED, OR IF IT HAS BEEN DROPPED."

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THEY HAVE THREE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS THAT WERE LEAKING DURING USE. THIS WAS FOUND DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307455 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1