BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2954689 · Received February 11, 2013

    Report

    Report Number
    9611451-2013-00086
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 15, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE FOUR COMPLAINT MR290V CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4), ONE FROM LOT 120618 (MANUFACTURED JUNE 18, 2012) AND THREE FROM LOT 120627 (MANUFACTURED JUNE 27, 2012). THE CHAMBERS WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE CHAMBER DOMES WERE ALL CRACKED ALONG THE BASE, BELOW ONE OF THE PORTS AND STRETCHING ALONG THE BASE. ALL FOUR CHAMBERS HAD SMEARED PRINTING IN THE VICINITY OF THE CRACKING. IN THREE CASES WHITE RESIDUE WAS FOUND AROUND THE CRACKING. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THE TWO LOT NUMBERS. CONCLUSION: FROM THE RESIDUE, THE SMEARED PRINTING AND THE NATURE OF THE CRACKING OBSERVED ON THE CHAMBER, WE CAN CONCLUDE THAT THE DAMAGE WAS CAUSED BY ENVIRONMENTAL STRESS CRACKING DUE TO THE CHAMBER DOME COMING INTO CONTACT WITH CLEANING PRODUCTS, SPECIFICALLY PRODUCTS THAT ARE ALCOHOL-BASED. BASED ON OUR INSPECTION OF THE RETURNED DEVICE, THE SMEARED FINGERPRINTS ON THE CHAMBER DOME INDICATE THAT THE DOME CAME IN CONTACT WITH CLEANING SOLUTIONS CONTAINING ETHANOL, WHICH RESULTED IN THE CRACKING OF THE CHAMBER. THE MR290 HUMIDIFICATION CHAMBER IS A SINGLE USE DEVICE, MANUFACTURED IN A CLEAN WORKING ENVIRONMENT AND AS SUCH DOES NOT NEED TO BE CLEANED. TO THIS END OUR USER INSTRUCTIONS STATE: "DO NOT SOAK, WASH, STERILISE OR REUSE THIS PRODUCT". EVERY MR290 CHAMBER IS PRESSURE TESTED TO (B)(4) 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 (B)(4). (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AS SOON AS THEY SET UP AN MR290 AUTOFEED HUMIDIFICATION CHAMBER, WATER LEAKED AT THE CONNECTION BETWEEN THE CHAMBER DOME AND THE BASE. THIS HAPPENED WITH FOUR MR290 CHAMBERS. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58129 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120618

    Patients

    Seq Age Sex Outcome Treatment
    1