BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3260718 · Received August 2, 2013

    Report

    Report Number
    9611451-2013-00574
    Event Type
    Malfunction
    Date Received
    August 2, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 5, 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 MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED THAT THE CHAMBER WAS RETURNED WITHOUT THE PORT CAPS AND THE FEEDSET TUBE WINDER. FLUID WAS ALSO FOUND INSIDE THE FEEDSET TUBE SUGGESTING THAT THE CHAMBER HAS BEEN USED. THE CHAMBER DOME WAS CRACKED. THE CRACK WAS OBSERVED TO STRETCH AROUND THE BASE. A SECOND CRACK WAS NOTED AT THE BAFFLE. THE PRINT AROUND THE BAFFLE WAS SMEARED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130124. CONCLUSION: BASED ON THE SMEARED PRINT AND THE NATURE OF THE CRACKING OBSERVED ON THE RETURNED CHAMBER, WE CAN CONCLUDE THAT THE DAMAGE WAS CAUSED BY ENVIRONMENTAL STRESS CRACKING DUE TO THE CHAMBER DOME COMING INTO CONTACT WITH ALCOHOL BASED CLEANING SOLUTIONS. THE MR290 AUTOFEED HUMIDIFICATION CHAMBER IS A SINGLE USE DEVICE, MANUFACTURED IN A CLEAN WORKING ENVIRONMENT AND DOES NOT REQUIRE ANY CLEANING. TO THIS END OUR USER INSTRUCTIONS STATE: "DO NOT SOAK, WASH, STERILISE OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." EVERY MR290 CHAMBER IS PRESSURE TESTED TO 8KPA FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. FISHER & PAYKEL HEALTHCARE'S USER INSTRUCTIONS THAT ACCOMPANY THE MR290 CHAMBER SPECIFY TO THE USER TO "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT", TO REFRAIN FROM USING THE CHAMBER IF IT HAS BEEN DROPPED AND "TO SET THE APPROPRIATE VENTILATOR ALARMS" IN THE EVENT A LEAK OCCURS. IT ALSO STATES THAT THE MAXIMUM OPERATING PRESSURE IS 8KPA. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT A CRACK WAS FOUND AROUND THE CHAMBER DOME AND BASE PLATE OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER. IT WAS REPORTED THAT THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363134 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 130124

    Patients

    Seq Age Sex Outcome Treatment
    1 FPH RT236 INFANT BREATHING CIRCUIT