BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3054259 · Received April 11, 2013

    Report

    Report Number
    9611451-2013-00268
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 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
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICES ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FIVE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. TWO OF THESE CHAMBERS WERE FROM LOT 120809, TWO WERE FROM LOT 120724 AND ONE WAS FROM LOT 120713. ALL THE RETURNED CHAMBERS WERE VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED CRACKS ON THE CHAMBER DOMES ON ALL FIVE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS. THESE CRACKS WERE FOUND BELOW THE BAFFLE ON TWO CHAMBERS AND BELOW ONE OF THE PORTS ON THE OTHER THREE CHAMBERS. THE CRACKS STRETCHED ALONG THE BASE OF THE CHAMBER AND A SMALL AMOUNT OF RESIDUE WAS IDENTIFIED AROUND THE CRACK ON ALL FIVE CHAMBERS. A DENT WAS ALSO NOTED ON THE BASE ON FOUR OF THE FIVE RETURNED MR290V CHAMBERS. A LOT CHECK REVEALED TWO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120809. CONCLUSION: BASED ON THE RESIDUE IDENTIFIED AND THE NATURE OF THE CRACKING OBSERVED ON THE RETURNED MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS, 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 HOSPITAL HAS FURTHER INFORMED US THAT A DISINFECTANT DISPENSER WAS LOCATED 20CM FROM THE CHAMBERS AND THAT IT WAS POSSIBLE FOR THE CHAMBERS TO COME INTO CONTACT WITH THE DISINFECTANTS. THE MR290V VENTED 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." 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 HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT WATER WAS LEAKING FROM THE CONNECTION BETWEEN THE CHAMBER DOME AND BASE PLATE ON FIVE MR290 AUTOFEED HUMIDIFICATION CHAMBERS AFTER SEVEN DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(4) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT WATER WAS LEAKING FROM THE CONNECTION BETWEEN THE CHAMBER DOME AND BASE PLATE ON FIVE MR290 AUTOFEED HUMIDIFICATION CHAMBERS AFTER SEVEN DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156061 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120713

    Patients

    Seq Age Sex Outcome Treatment
    1