BEUDAMED
    FDA Adverse Event Summary report: N

    CAREFUSION

    MDR report key: 3170655 · Received June 10, 2013

    Report

    Report Number
    2021710-2013-00047
    Date Received
    June 10, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    CAREFUSION
    Product Code
    BZD
    PMA / PMN Number
    K974303
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFORMATION DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO AN EMAIL RECEIVED FROM A USER FACILITY REPRESENTATIVE. (B)(4). CAREFUSION SENT A LETTER TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE PATIENT. AS OF (B)(4) 2013, THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. AS REPORTED BY THE USER FACILITY, THE ANATOMICAL SHAPE OF THE PATIENT'S NOSE MADE PROPER FITTING OF BOTH THE NASAL PRONGS AND MASK DIFFICULT THUS RESULTING IN SKIN BREAKDOWN. BASED ON THE AVAILABLE CUSTOMER INFORMATION, CAREFUSION HAS CONCLUDED THAT THE ANATOMICAL SHAPE OF THE PATIENT'S NOSE MAY HAVE BEEN A CONTRIBUTING FACTOR OF THE REPORTED EVENT. SHOULD ADDITIONAL INFORMATION BECAME AVAILABLE A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS REPORTED TO CAREFUSION BY THE USER FACILITY VIA EMAIL. "WE HAVE AN INFANT IN THE NICU WITH SEPTAL EROSION/ BREAKDOWN WHILE RECEIVING CPAP/ SIPAP. WE HAVE TRIED TO USE THE X-SMALL PRONGS ON THIS INFANT WITHOUT SUCCESS. THEY DID NOT FIT IN HER NOSE CORRECTLY IN THAT DAY DID NOT SEEM LONG ENOUGH DUE TO THE ANATOMICAL SHAPE OF HER NOSE AND SO THE STAFF WAS USING THE MASK FOR PRIMARY DELIVERY OF THE CPAP/ SIPAP THUS THE PRESSURE AND BREAKDOWN. THIS STARTED ON (B)(6). AT THE TIME I HAD THE STAFF PLACE MEPITEL AND MEPILEX ON THE SEPTUM AND THEN THE PHYSICIAN TEAM DECIDED ON SATURDAY TO DO (B)(4) SPRINTS TO "REST" THE SEPTAL AREA. I WAS WITH THE RN TODAY AND WE REMOVED ALL OF THE SKIN CARE PROTECTION TO GET A BETTER LOOK AT HOW THIS HAS BEEN WORKING AND ALTHOUGH THE RN SAID THERE IS IMPROVEMENT IT IS STILL SIGNIFICANT. AGAIN, WE PLACED THE MEPITEL AND MEPILEX FOR PROTECTION. TODAY ON ROUNDS THE PHYSICIAN AND NURSING TEAM DISCUSSED THE CONCERNS FOR FURTHER EROSION AND IT WAS DECIDED TO PLACE THE INFANT ON A VENTILATOR TO KEEP PRESSURE OFF THE SEPTUM, ALLOW FOR HEALING AND GROWTH, AND HAVE "PLASTICS" CONSULT FOR FURTHER TREATMENT CONCERNS." "WOULD YOU BE ABLE TO FOLLOW UP WITH THE CAREFUSION REPRESENTATIVE TO SEE IF OTHER FACILITIES ARE HAVING ANY ISSUES WITH THE PRONGS FOR THESE REALLY SMALL MICROPRE-EMIES (<600-700 GM) SMALL NARES THAT THE X-SMALL PRONGS DO NOT FIT, OR ARE TOO SHORT AND WHAT THEY ARE DOING TO PROTECT THE SKIN/ SEPTUM? ARE THEY ALTERNATING THE MASK AND PRONGS? WE HAVE BEEN ALTERNATING Q 3-6 HOURS AND MASSAGES WITH INSPECTION OF THE SKIN. I WOULD ALSO LIKE FOR STAN TO DO A DRILL DOWN ON THIS INFANT TO SEE IF WE CAN HAVE BETTER CLARITY TO HOW THIS MAY HAVE HAPPENED. WE HAVE BEEN DOING SO WELL WITH PREVENTION OF SKIN/ SEPTAL BREAKDOWN, SO WOULD LIKE TO SEE WHAT MAY HAVE BEEN THE CAUSE AND HOW WE CAN PREVENT THIS IN THE FUTURE AS WELL AS TALK WITH THE COMPANY TO SEE IF THERE ARE ANY OTHER RESOURCES TO DELIVER SIPAP/ CPAP TO THESE MICROPRE-EMIES WITH REALLY SMALL NARES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261431 CAREFUSION BZD CAREFUSION NASAL MASK/ PRONGS ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ASKU