BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2073488 · Received May 1, 2011

    Report

    Report Number
    9611451-2011-00276
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT BREATHING CIRCUIT IS NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE DESCRIPTION OF EVENTS AND OUR KNOWLEDGE OF THE PRODUCT. A LOT CHECK COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. THE HOSPITAL FURTHER REPORTED THAT THE PACKAGING WAS "THROWN AWAY" AND WITHOUT A COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM OBSERVED BY THE CUSTOMER. EACH BREATHING CIRCUIT KIT CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. THERE ARE STANDARD OPERATING PROCEDURES (SOPS) IN PLACE TO ASSIST OPERATORS ON THE PRODUCTION LINE CORRECTLY PACK BREATHING CIRCUITS. THIS CONSISTS OF A SPECIFIC PACK CARD DETAILING ALL COMPONENTS REQUIRED WHICH MUST BE DISPLAYED AT THE PACKING STATION. BEFORE LEAVING PRODUCTION, ALL BREATHING CIRCUITS ARE TESTED FOR ELECTRICAL RESISTANCE, LEAKS AND CONNECTIVITY. THIS IS AN AUTOMATED PROCESS AND THE CIRCUITS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THOSE THAT FAIL ARE REJECTED. THE MISSING PORT CAP WOULD HAVE CAUSED A PRESSURE DROP THAT WOULD HAVE BEEN DETECTED ON THE PRODUCTION LINE. THE ROOT CAUSE OF THE PROBLEM OBSERVED BY THE CUSTOMER CANNOT BE DETERMINED, HOWEVER, IT IS POSSIBLE THAT THE PORT CAP MAY HAVE BECOME LOOSE DURING TRANSPORT OR STORAGE AND LOST WHEN THE PACKAGE WAS OPENED. THE RT235 USER INSTRUCTIONS 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 THAT THE PORT CAP FROM THE Y-SWIVEL OF AN RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS "MISSING." THIS WAS FOUND PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT235 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1