BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 4521979 · Received February 17, 2015

    Report

    Report Number
    9611451-2015-00080
    Event Type
    Malfunction
    Date Received
    February 17, 2015
    Report Date
    January 19, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT FROM THE DISTRIBUTOR. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE RECEIVED THE COMPLAINT DEVICE AND COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP: ADDITIONAL INFORMATION WAS ADDED IN THE EVENT DESCRIPTION. MANUFACTURER NARRATIVE: THE COMPLAINT RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INSPECTION. WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO CONFIRM THE REPORTED FAULT AND DETERMINE ITS ROOT CAUSE. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 141020. ALL RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS, INCLUDING THE SWIVEL ASSEMBLIES, ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE HOSPITAL REPORTED THAT THE INCIDENT OCCURRED DURING USE ON A PATIENT, WHICH SUGGESTS THAT THE CONNECTION BECAME LOOSE POSSIBLY DURING PATIENT CARE. THE DISTRIBUTOR ALSO COMMENTED "IT'S POSSIBLE THE ERROR HAPPENED DUE TO THERAPIST USING TOO MUCH PRESSURE WHEN CONNECTING TO THE CIRCUIT". OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRUCIT STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE SWIVEL Y-PIECE OF AN RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT BECAME DETACHED FROM THE ENDOTRACHEAL TUBE DURING USE. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE SWIVEL Y-PIECE OF AN RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT BECAME DETACHED FROM THE ENDOTRACHEAL TUBE DURING USE AND THE PATIENT'S OXYGEN LEVEL DESATURATED. HOWEVER, NO PATIENT HARM WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112596 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT266 141020

    Patients

    Seq Age Sex Outcome Treatment
    1