BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3801397 · Received May 8, 2014

    Report

    Report Number
    9611451-2014-00416
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 11, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT236 NEONATAL BREATHING CIRCUIT WAS JUST RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(6) FOR EVALUATION. A FOLLOW UP REPORT WILL BE PROVIDED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT236 INFANT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A 12MM CUT ALONG THE LENGTH OF THE INSPIRATORY LIMB OF THE CIRCUIT. A LOT CHECK COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: THE DAMAGE OBSERVED ON THE RETURNED INSPIRATORY LIMB INDICATES THAT IT WAS PUNCTURED BY A SHARP OBJECT. MOST LIKELY DUE TO THE BOX OR DEVICE BAG BEING OPENEND WITH A KNIFE OR BOXCUTTER. ALL RT236 BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAK PRIOR TO DISTRIBUTION. ANY BREATHING CIRCUIT WHICH DOES NOT PASS THE PRESSURE TEST IS DISCARDED. THE SUBJECT RT236 INFANT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THIS SUGGESTS THAT THE AFFECTED BREATHING CIRCUIT WAS DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT236 INFANT BREATHING CIRCUIT STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "USE CAUTION WHEN POSITIONING THE CIRCUIT. SHARP OR HARSH EDGES AND SURFACES MAY DAMAGE THE EXPIRATORY LIMB." "SET APPROPRIATE VENTILATOR ALARMS." THE DEVICE BOX ALSO HAS VISUAL INDICATIONS NOT TO USE SHARP OBJECTS TO OPEN THE BOX. THE HOSPITAL STAFF CORRECTLY CHECKED THE SUBJECT RT236 INFANT BREATHING CIRCUIT PRIOR TO PATIENT USE. THIS IS IN LINE WITH OUR USER INSTRUCTIONS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT A HOLE WAS FOUND IN AN RT236 NEONATAL BREATHING CIRCUIT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT A HOLE WAS FOUND IN AN RT236 NEONATAL BREATHING CIRCUIT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278955 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT236

    Patients

    Seq Age Sex Outcome Treatment
    1