BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 3831680 · Received May 26, 2014

    Report

    Report Number
    9611451-2014-00435
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 29, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K122432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONLY ONE COMPLAINT RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) FOR INVESTIGATION. THIS CIRCUIT WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: A CUT WAS FOUND IN THE EXPIRATORY LIMB OF THE COMPLAINT CIRCUIT. THE CUT WAS ABOUT 68 CM FROM THE PATIENT END. THE DAMAGE APPEARED TO HAVE BEEN MADE WITH A SHARP OBJECT, SUCH AS A KNIFE OR BOX CUTTER. A LOT CHECK HAS REVEALED NO SIMILAR COMPLAINTS FOR LOT NUMBER 131015. CONCLUSION: BASED ON OUR EXPERIENCE OF OTHER SIMILAR INVESTIGATIONS, WE CAN CONCLUDE THAT THE DAMAGE MOST LIKELY OCCURRED WHEN THE CIRCUIT PACKAGING BOX WAS OPENED. ALL RT380 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS BEFORE RELEASING FOR DISTRIBUTION. ANY BREATHING CIRCUIT WHICH FAILS ANY OF THESE TESTS IS DISCARDED. IN ADDITION, TUBE WEIGHING AND BOND STRENGTH TESTING ARE PERFORMED EVERY 15 MINUTES. IF ANY FAULTS ARE DETECTED THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. THE USER INSTRUCTIONS SUPPLIED WITH THE RT380 BREATHING CIRCUIT STATE: - PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. - SET APPROPRIATE VENTILATOR ALARMS. THE HOSPITAL STAFF CORRECTLY CHECKED THE BREATHING CIRCUIT BEFORE PATIENT USE WHICH IS IN LINE WITH OUR USER INSTRUCTIONS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT TWO RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITS WERE LEAKING. ONE CIRCUIT HAD A VISIBLE CRACK. THIS WAS DISCOVERED BEFORE USE ON A PATIENT WHILST PERFORMING AN AIR TIGHTNESS CHECK ON THE VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309979 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT380 131015

    Patients

    Seq Age Sex Outcome Treatment
    1