BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3450878 · Received November 5, 2013

    Report

    Report Number
    9611451-2013-00882
    Event Type
    Malfunction
    Date Received
    November 5, 2013
    Date of Event
    October 9, 2013
    Report Date
    October 10, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: 130305, MANUFACTURING DATE: 03/05/2013, QUANTITY AFFECTED: 1; 130307, 03/07/2013, 1. METHOD: THE TWO COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FPH IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE CHAMBER WITH LOT NUMBER 130305 WAS CRACKED BELOW THE BRACKET, STRETCHING ALONG THE BASE. THE PRINTING ON THE CHAMBER WAS SMEARED AROUND THE DOME. THE CHAMBER WITH LOT NUMBER 130307 WAS CRACKED BELOW ONE OF THE PORTS, WHICH ALSO STRETCHED ALONG THE BASE. THE PRINTING ON THE CHAMBER WAS SMEARED IN THE VICINITY OF THE CRACK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR BOTH LOT NUMBERS. CONCLUSION: THE NATURE OF THE CRACKING AND THE SMEARED PRINT ON THE CHAMBER DOMES INDICATE THAT THE DAMAGE WAS CAUSED BY ENVIRONMENTAL STRESS CRACKING DUE TO THE CHAMBER DOME COMING INTO CONTACT WITH A SOLUTION CONTAINING ETHANOL. 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 FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DUE TO CRACKS AND OTHER CAUSES. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS EITHER OF THESE TESTS IS REJECTED. THIS SUGGESTS THAT THE CRACKING OCCURRED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 AUTOFEED HUMIDIFICATION CHAMBER 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." (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS ARE EN ROUTE TO FPH IN (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS LEAKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS LEAKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568501 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT| RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT| LEONIE PLUS VENTILATOR| LEONIE PLUS VENTILATOR