BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3103832 · Received May 9, 2013

    Report

    Report Number
    9611451-2013-00374
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 12, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ENDEAVOURING TO RETRIEVE THE COMPLAINT DEVICE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290V CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE CHAMBER DOME WAS CRACKED ALONG THE BASE, BELOW THE BAFFLE. THE CHAMBER HAD SMEARED PRINTING IN THE VICINITY OF THE CRACKING. RESIDUE WAS FOUND IN THE VICINITY OF THE CRACK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 121123. 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 PRINTING ON THE CHAMBER DOME INDICATES 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 A PATIENT WAS USING A SETUP WHICH INCLUDED AN RT340 ADULT BREATHING CIRCUIT AND AN MR290 AUTOFEED HUMIDIFICATION CHAMBER WHEN THE VENTILATOR ALARMED TO INDICATE LEAKAGE IN THE SYSTEM. THEY REPORTED THAT WATER LEAKED FROM THE HUMIDIFICATION CHAMBER AND EMPTIED THE BAG OF STERILE WATER. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A PATIENT WAS USING A SETUP WHICH INCLUDED AN RT340 ADULT BREATHING CIRCUIT AND AN MR290 AUTOFEED HUMIDIFICATION CHAMBER WHEN THE VENTILATOR ALARMED TO INDICATE LEAKAGE IN THE SYSTEM. THEY REPORTED THAT WATER LEAKED FROM THE HUMIDIFICATION CHAMBER AND EMPTIED THE BAG OF STERILE WATER. THE PATIENT WAS DISCONNECTED FROM THE VENTILATOR AND MANUALLY VENTILATED AS PER THE STANDARD PROCEDURE WHILE A COLLEAGUE REPLACED THE SYSTEM. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202836 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 121123

    Patients

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