BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT CPAP NASAL PRONG

    MDR report key: 1212578 · Received October 24, 2008

    Report

    Report Number
    9611451-2008-00620
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    July 15, 2008
    Report Date
    September 24, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    BZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS CONDUCTED BASED ON THE EVENT DESCRIPTION AND RESULTS OF PREVIOUS INVESTIGATIONS, AS THE COMPLAINT DEVICE HAD NOT BEEN RETURNED FOR INVESTIGATION. RESULTS: BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL, THE NASAL PRONGS WERE NOT INSERTED ACCORDING TO FISHER & PAYKEL HEALTHCARE'S USER INSTRUCTIONS. IN ADDITION, THE HOSPITAL FURTHER REPORTED THAT THE INFANT'S SKIN INTEGRITY IN THE SEPTAL AREA WAS NOT CHECKED WITH ENOUGH FREQUENCY. CONCLUSION: IT IS WELL KNOWN (THROUGH PUBLISHED LITERATURE), THAT NASAL CPAP REQUIRES CAREFUL MANAGEMENT TO AVOID THE POTENTIAL SIDE EFFECT OF SEPTAL EROSION, AS THE TISSUE AROUND THE NASAL SEPTUM CAN BREAK DOWN IF SUBJECTED TO CONTINUOUS PRESSURE, FRICTION OR MOISTURE. OUR USER INSTRUCTIONS SUPPLIED WITH THE CPAP INTERFACE ILLUSTRATE THE CORRECT INTERFACE SET-UP ON THE PATIENT AND CLEARLY DIRECT USERS TO ENSURE THAT THE NASAL PRONGS ARE POSITIONED WITH AT LEAST A 2 MM GAP FROM THE SEPTUM TO AVOID PRESSURE NECROSIS. THE NASAL SEPTAL DAMAGE CAN BE PREVENTED WITH APPROPRIATE CARE AND ATTENTION FROM MEDICAL PROFESSIONALS. OUR MONITORING AND TRENDING FOR INFANT CPAP NASAL SEPTAL DAMAGE HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 37 PPM.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THE FOLLOWING: AN INFANT IN THEIR NICU WAS RECEIVING NASAL CPAP THERAPY VIA AN AVILLA VENTILATOR USING THE FISHER & PAYKEL HEALTHCARE INTERFACE WITH AN INFANT CPAP NASAL PRONG. OVER THE COURSE OF 12 HOURS AFTER PLACING THE INFANT ON THAT SET-UP, THE SEPTUM DEVELOPED A PRESSURE SORE WHICH TURNED NECROTIC AND THE INFANT LOST A PORTION OF THE NASAL SEPTUM; AND THE NASAL PRONGS WERE NOT INSERTED ACCORDING TO THE MANUFACTURER'S USER INSTRUCTIONS AND THE INFANT'S SKIN INTEGRITY IN THE SEPTAL AREA WAS NOT ASSESSED WITH ENOUGH FREQUENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT CPAP NASAL PRONG BZO FISHER & PAYKEL HEALTHCARE LTD. BC4030

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Disability AVILLA VENTILATOR