BEUDAMED
    FDA Adverse Event Other Summary report: N

    HORIZON PUMP SYRINGE ADD-ON SET

    MDR report key: 917367 · Received September 21, 2007

    Report

    Report Number
    2647836-2007-00011
    Event Type
    Other
    Date Received
    September 21, 2007
    Date of Event
    July 30, 2007
    Report Date
    August 17, 2007
    Manufacturer
    B. BRAUN MEDICAL OF PUERTO RICO, INC.
    Product Code
    FPA
    PMA / PMN Number
    K904518
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS NOT RETURNED FOR EVALUATION AND A LOT NUMBER WAS NOT REPORTED. WITHOUT THE ACTUAL SAMPLE AND A LOT NUMBER, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP PER THE USER FACILITY: THE TUBING LEAKED, SITE UNK. INFUSING LIPIDS INTO ONE MONTH OLD PREEMIE WITH RESPIRATORY DISTRESS. ADDITIONAL INFORMATION PROVIDED BY THE USER FACILITY INDICATED THE EXTENSION SET WAS NOTED TO LEAK AT THE HUB. THE ADMINISTRATION WAS STOPPED BRIEFLY AND THE SET WAS CHANGED WITHOUT INCIDENT AND WITHOUT ANY DISTRESS TO THE INFANT. THE INFANT SUFFERED NO ADVERSE SEQUELA ASSOCIATED WITH THIS INCIDENT. THE SET WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. THE LOT NUMBER WAS NOT OBTAINABLE SINCE THE PACKAGING WAS DISCARDED. IT WAS REPORTED THAT THE FACILITY'S CURRENT INVENTORY DOES NOT REFLECT THE INVENTORY AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON PUMP SYRINGE ADD-ON SET HORIZON PUMP EXTENSION SET FPA B. BRAUN MEDICAL OF PUERTO RICO, INC. ET82HP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other