BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HME NEONATE & INFANT HCH 50/CS

    MDR report key: 2972807 · Received February 21, 2013

    Report

    Report Number
    2050001-2013-00003
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 28, 2013
    Manufacturer
    CAREFUSION
    Product Code
    BYD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT INVOLVED IN THE REPORTED ISSUE HAS NOT BEEN RETURNED FOR EVALUATION. A FOLLOW UP WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT PROVIDED, AN EVALUATION COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THIS LOT OF PRODUCT. THERE WERE NO ISSUES IDENTIFIED DURING THE MANUFACTURE OF THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    CUSTOMER DISSATISFACTION PATIENT STATES: THE HME'S THAT WERE SENT TO THE PATIENT ARE DIFFERENT THAN WHAT THEY USE TO GET.  THEY ARE A DIFFERENT MANUFACTURER.  PATIENT'S PREVIOUS HME PWA P/N 10011 THE REPLACEMENT FOR THIS HME IS SIMILAR, BUT HAS A FOAM FILTER INSTEAD OF PAPER.  THE FOAM MOVES WHEN THE PATIENT BREATHES AND COMES OUT WHEN HE COUGHS.  PER THE MOTHER THIS IS NOT AN ACCEPTABLE REPLACEMENT FOR WHAT SHE WAS USING BEFORE.  ADDITIONAL INFORMATION OBTAINED FROM THE REPORTING FACILITY ON (B)(6) 2013.  THE PATIENT IS (B)(6) AND USES THE HME DURING THE DAY ONLY.  THE HME IS CONNECTED DIRECTLY TO THE TRACH.  THE CUSTOMER IS AWARE THAT THIS PRODUCT IS INTENDED FOR INFANTS.  HOWEVER, IT IS PREFERRED BECAUSE OF ITS SMALL SIZE. THE CUSTOMER IS NOT USING THIS PRODUCT ANY LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76843 HME NEONATE & INFANT HCH 50/CS CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE) BYD CAREFUSION 003011-A SJ0212013

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR