BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERMEDIATE INFANT OXY THERAPY NASAL CANNULA

    MDR report key: 1148276 · Received September 4, 2008

    Report

    Report Number
    9611451-2008-00518
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    April 7, 2008
    Report Date
    August 11, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    CAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBER. AN INVESTIGATION WILL BE CONDUCTED ONCE WE RECEIVE THE COMPLAINT DEVICE. A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THAT A REPAIRED TRACHEO-OESOPHAGEAL FISTULA NEONATE DEVELOPED RESPIRATORY DISTRESS WHILST CARED FOR IN NNU. THE BABY HAD HUMIDIFIED OXYGEN DELIVERED AT 5 L/MIN VIA BC2755 INTERMEDIATE INFANT OXYGEN THERAPY NASAL CANNULA. THIS WAS EFFECTIVELY GIVING THE BABY UNCONTROLLED CPAP. BECAUSE THE PRODUCT IS LABELLED MAXIMUM INPUT FLOW OF 8 L/MIN, THE NURSING STAFF THOUGHT 5 L/MIN WAS ALRIGHT. THE BABY WAS IMMEDIATELY CHANGED TO HEAD BOX OXYGEN AND CONTINUED TO STRUGGLE, SO INTUBATION AND VENTILATION WERE REQUIRED. THE NASAL CANNULA DID NOT CAUSE THE LEAK BUT DID EXACERBATE IT'S CLINICAL EFFECT. THE NASAL CPAP IS CONTRAINDICATED TO TRACHEO-OESOPHAGEAL FISTULA CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMEDIATE INFANT OXY THERAPY NASAL CANNULA CAT FISHER & PAYKEL HEALTHCARE, LTD. BC2755 061007

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FISHER & PAYKEL HEALTHCARE RT329 OXYGEN THERAPY| SYSTEM