BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRATORY BACTERIAL/VIRAL FILTER

    MDR report key: 5509622 · Received March 17, 2016

    Report

    Report Number
    9611451-2016-00102
    Event Type
    Malfunction
    Date Received
    March 17, 2016
    Date of Event
    October 29, 2015
    Report Date
    November 2, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAH
    PMA / PMN Number
    K133666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FISHER & PAYKEL HEALTHCARE RT016 INSPIRATORY FILTER IS INTENDED FOR USE BETWEEN A VENTILATOR AND BREATHING CIRCUIT. ITS FUNCTION IS TO REMOVE MICROBIOLOGICAL AND PARTICULATE MATTER FROM GASES ENTERING A BREATHING CIRCUIT. THE RT016 IS INTENDED TO BE CONNECTED TO THE VENTILATOR INSPIRATORY PORT. IT IS NOT DIRECTIONAL IN TERMS OF FLOW AND IS A SINGLE USE DEVICE. UPON INVESTIGATION, IT WAS REVEALED THAT OF THE REPORTED 10 COMPLAINT RT016 INSPIRATORY FILTERS (6X LOT 150513, MANUFACTURED ON 13 MAY 2015; 4X LOT INFORMATION NOT PROVIDED), ONLY SIX FILTERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. THESE FILTERS WERE RETURNED IN A SEALED PACKAGE. WE THEREFORE COULD NOT INVESTIGATE THE USED COMPLAINT FILTER(S) AND COULD NOT CONFIRM THE REPORTED EVENT. METHOD: THE SIX RT016 FILTERS (6X LOT 150513), WHICH WERE RETURNED IN A SEALED PACKAGE, WERE REMOVED FROM THE PACKAGE AND VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: VISUAL INSPECTION REVEALED NO DAMAGE TO ANY OF THE RETURNED FILTERS. THE PRESSURE TESTS CONDUCTED SHOWED THAT ALL FILTERS WERE WITHIN SPECIFICATION. CONCLUSION: NO FAULT WAS FOUND WITH THE RETURNED FILTERS BASED ON THE INVESTIGATION CONDUCTED. AS THE TESTED SIX FILTERS WERE RETURNED IN A SEALED PACKAGE AND NO USED COMPLAINT FILTER WAS RETURNED, WE ARE UNABLE TO DETERMINE WHAT HAD CAUSED THE LEAK REPORTED BY THE HOSPITAL. ALL RT016 INSPIRATORY FILTERS ARE PRESSURE TESTED FOR LEAKS BEFORE LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT RT016 FILTERS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT016 INSPIRATORY FILTER STATE: CHANGE (FILTER) EVERY 24 HOURS OR SOONER IF NOTICEABLE DETERIORATION OCCURS, FOLLOWING STANDARD HOSPITAL PROCEDURE WHEN NEBULIZED DRUGS ARE USED RESISTANCE TO FLOW SHOULD BE MONITORED AND THE PRODUCT REPLACED, FOLLOWING STANDARD HOSPITAL PROCEDURE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE RT016 INSPIRATORY FILTER OF AN RT319 CIRCUIT FAILED THE VENTILATOR LEAK TEST. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163692 INSPIRATORY BACTERIAL/VIRAL FILTER CAH CAH FISHER & PAYKEL HEALTHCARE LTD RT016 150513

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE RT319 BREATHING CIRCUIT