BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2582356 · Received May 21, 2012

    Report

    Report Number
    9611451-2012-00281
    Event Type
    Malfunction
    Date Received
    May 21, 2012
    Date of Event
    April 11, 2012
    Report Date
    April 11, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT265 INFANT 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 K034026. METHOD: THE COMPLAINT RT265 INFANT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED FOR MISSING PORT PLUGS. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED BREATHING CIRCUIT. FURTHER INSPECTION REVEALED THAT THE PORT PLUG OF THE EXPIRATORY TUBE WAS NOT MISSING BUT RATHER LOOSE INSIDE THE PACKAGING. THE PORT PLUG OF THE DRY LINE HAD COME LOOSE AS WELL. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120125. CONCLUSION: WE WERE UNABLE TO DETERMINE THE ROOT CAUSE OF THE LOOSE PORT PLUGS. ALL PORT PLUGS ARE FULLY AND FIRMLY PRESSED INTO THE BREATHING CIRCUIT CONNECTORS BEFORE PACKAGING. MOREOVER, ALL BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED PRIOR TO LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT IT IS LIKELY THAT THE PORT PLUGS BECAME LOOSE POST PRODUCTION, POSSIBLY DURING TRANSPORTATION OR STORAGE. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF THIS NATURE FOR THIS PRODUCT.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT THE "WHITE CAP OF THE TUBING" OF AN RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS MISSING. THIS WAS NOTICED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT265 120125

    Patients

    Seq Age Sex Outcome Treatment
    1