BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 4628865 · Received March 24, 2015

    Report

    Report Number
    9611451-2015-00162
    Event Type
    Malfunction
    Date Received
    March 24, 2015
    Date of Event
    February 18, 2015
    Report Date
    February 23, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT235 INFANT BREATHING CIRCUIT KIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) IN A MINGRIP PLASTIC BAG. THE CONTENTS WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE 22F/12M LUER PORT CONNECTOR WAS MISSING. CRACKS, SCUFF MARKS, AND STRESS MARKS WERE FOUND AROUND THE AREA WHERE THE LUER PORT SHOULD BE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130924. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. HOWEVER, THE SCUFF MARKS AND STRESS MARKS PRESENT INDICATE THAT THE LUER PORT WAS MOST LIKELY CUT FROM THE CONNECTOR. THERE ARE STANDARD OPERATING PROCEDURES IN PLACE TO ASSIST OPERATORS ON THE PRODUCTION LINE TO CORRECTLY PACK THE BREATHING CIRCUITS. THIS CONSISTS OF A SPECIFIC PACK CARD DETAILING ALL COMPONENTS REQUIRED WHICH MUST BE DISPLAYED AT THE PACKING STATION. ALL INFANT BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS, AND VISUALLY INSPECTED FOR DEFECTS SUCH AS CRACKS, TEARS AND DEFORMATION PRIOR TO LEAVING THE PRODUCTION LINE. THOSE THAT FAIL ARE REJECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT 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 WHEN THEY OPENED AN RT235 INFANT BREATHING CIRCUIT KIT, THEY NOTICED THAT THE END CONNECTOR OF THE DRYLINE HAD BEEN DAMAGED. THEY FURTHER REPORTED THAT THEY COULD NOT FIND THE LUER PORT OR THE LUER PORT CAP IN THE PACKAGE. THIS WAS FOUND PRIOR TO USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196694 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT235 130924

    Patients

    Seq Age Sex Outcome Treatment
    1