BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR INTERFACE

    MDR report key: 2962837 · Received February 14, 2013

    Report

    Report Number
    9611451-2013-00084
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 17, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT OPT318 CANNULA AND RT330 CIRCUIT WERE RETURNED TO THE FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. THE COMPLAINT CANNULA WAS VISUALLY INSPECTED AND A PULL TEST WAS PERFORMED ON THE SWIVEL CLIP. RESULTS: THE VISUAL INSPECTION REVEALED NO DAMAGE TO THE COMPLAINT CANNULA. THE PULL TEST IDENTIFIED THE SWIVEL CLIP TO BE WITHIN SPECIFICATION FOR THIS PRODUCT. A LOT CHECK WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: NO FAULT WAS FOUND WITH THE RETURNED COMPLAINT CANNULA AND RT330 CIRCUIT. THE OPTIFLOW JUNIOR CANNULA IS DESIGNED SPECIFICALLY FOR THE DELICATE ANATOMICAL FEATURES AND FLOW REQUIREMENTS OF NEONATAL AND PEDIATRIC PATIENTS. IT FEATURES ADHESIVE PADS TO MAINTAIN CANNULA STABILITY ON THE PATIENT'S CHEEKS, SOFT-TOUCH NASAL PRONGS AND BREATHABLE KINK-PROOF AND CRUSH-RESISTANT FLEXIBLE TUBING. THE OPTIFLOW JUNIOR PROVIDES REVOLUTIONARY STEP BETWEEN LOW-FLOW OXYGEN THERAPY AND CPAP. EXISTING NASAL CANNULA SUITABLE FOR HIGH FLOW THERAPIES ARE COMPARATIVELY RIGID AND DIFFICULT TO APPLY. THEY CAN ALSO BE DIFFICULT TO INTENTIONALLY DISCONNECT FROM THE HEATED TUBE WITHIN THE CONFINES OF AN INCUBATOR IN SITUATIONS WHERE THE CONNECTION HAD BEEN PREVIOUSLY OVER TIGHTENED. THIS IS DUE TO THE EXISTING TAPER CONNECTION PREVIOUSLY USED. THE EASY-CLICK SWIVEL CONNECTION BETWEEN THE OPTIFLOW JUNIOR CANNULA AND THE BREATHING CIRCUIT IS DESIGNED TO DISCONNECT UNDER A MORE CONSISTENT DISCONNECTION FORCE, INDEPENDENTLY OF THE PREVIOUS CONNECTION FORCE. THIS ALLOWS THE CAREGIVER TO DISCONNECT MORE EASILY IN DELICATE SITUATIONS WITH PREMATURE BABIES. THE CANNULA IS ALSO DESIGNED TO DISCONNECT UNDER AN EXCESSIVE LOAD TO PREVENT THESE FORCES FROM BEING TRANSFERRED TO THE PATIENT. OUR USER INSTRUCTIONS THAT ACCOMPANY THE PRODUCT STATE THE FOLLOWING: "UNDER EXCESSIVE LOAD, THE CANNULA MAY DISCONNECT TO PREVENT FORCES FROM BEING TRANSFERRED TO THE PATIENT. ENSURE THAT ALL CONNECTIONS ARE SECURE DURING USE." "PATIENT MONITORING IS RECOMMENDED."

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT OPT318 CANNULA AND RT330 CIRCUIT WERE RETURNED TO THE FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS AND WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION. INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE OPT318 OPTIFLOW JUNIOR CANNULA HAD BECOME DISCONNECTED FROM THE RT330 CIRCUIT. THE OPTIFLOW JUNIOR CANNULA WAS RECONNECTED BY THE HOSPITAL STAFF. THE LENGTH OF TIME OF DISCONNECTION IS UNKNOWN. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE OPT318 OPTIFLOW JUNIOR CANNULA HAD BECOME DISCONNECTED FROM THE RT330 CIRCUIT. THE OPTIFLOW JUNIOR CANNULA WAS RECONNECTED BY THE HOSPITAL STAFF. THE LENGTH OF TIME OF DISCONNECTION IS UNKNOWN. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64460 OPTIFLOW JUNIOR INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT318

    Patients

    Seq Age Sex Outcome Treatment
    1