BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 8468136 · Received March 31, 2019

    Report

    Report Number
    9611451-2019-00308
    Event Type
    Malfunction
    Date Received
    March 31, 2019
    Date of Event
    February 4, 2019
    Report Date
    March 2, 2019
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PS304049 THE RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K103767. METHOD: THE RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR INVESTIGATION. THE INVESTIGATION IS THUS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. RESULTS: WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO CONFIRM THE REPORTED FAULT AND UNABLE TO DETERMINE IF THE DISCONNECTION WAS DUE TO A FAULT WITH THE COMPLAINT DEVICE. THE CUSTOMER STATED THAT THE DISCONNECTION OCCURED AT THE INSPIRATORY ELBOW OF THE CHAMBER AFTER THE CIRCUIT WAS HANDLED. THE REPORTED DISCONNECTION WAS MOST LIKELY DUE TO THE CUSTOMER ACCIDENTLY PULLING THE CIRCUIT WHILE HANDLING THE CIRCUIT. ALL RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT ARE VISUALLY INSPECTED, AND PRESSURE AND FLOW TESTED DURING PRODUCTION. ANY BREATHING CIRCUITS THAT FAIL THESE TESTS ARE REJECTED. THE SUBJECT RT265 INFANT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT STATE THE FOLLOWING: - "DO NOT STRETCH OR MILK THE TUBING" - "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 · 0

    A HEALTHCARE FACILITY IN THE UK REPORTED THAT AN RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS DISCONNECTED DURING USE. THE PATIENT EXPERIENCED A DECREASED OXYGEN SATURATION LEVEL AND HEART RATE AND REQUIRED MANUAL HYPERVENTILATION. RESPIRATORY RESUSCITATION WAS REQUIRED AND INCREASED PRESSURE ON THE VENTILATOR. IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXTUBATED AND HAS BEEN DISCHARGED WITHOUT FURTHER CONSEQUENCES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K103767. WE ARE IN PROCESS TO DETERMINE IF THE RT 268 CIRCUIT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS DISCONNECTED DURING USE. THE PATIENT EXPERIENCED A DECREASED OXYGEN SATURATION LEVEL AND HEART RATE AND REQUIRED MANUAL HYPERVENTILATION. RESPIRATORY RESUSCITATION WAS REQUIRED AND INCREASED PRESSURE ON THE VENTILATOR. IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXTUBATED AND HAS BEEN DISCHARGED WITHOUT FURTHER CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261277 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT268 2100576741

    Patients

    Seq Age Sex Outcome Treatment
    1