BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3883883 · Received June 11, 2014

    Report

    Report Number
    9616066-2014-00604
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 24, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. NO PRODUCT WILL BE RETURNED PER THE CUSTOMER; HOWEVER, PHOTOGRAPHS OF THE SET UP WERE PROVIDED. ALTHOUGH IT APPEARS THAT A SMALL AMOUNT OF MILKY FLUID, PRESUMED TO BE INTRALIPID, MAY HAVE BACKED UP TOWARD THE TPN FILTER, THE REPORT OF BLOOD BACKING UP INTO THE TPN SET COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BLOOD AND LIPIDS WERE NOTED TO BE BACKING UP INTO THE TPN SET 45 MINUTES INTO THE INFUSION. THE TPN WAS INFUSING AT 3.8ML/HOUR AND THE LIPIDS RATE WAS NOT PROVIDED, BOTH INFUSIONS WERE CONNECTED TO A STOPCOCK. WHEN DETAILS WERE REQUESTED TO DETERMINE WHETHER OR NOT PATIENT HARM HAD OCCURRED, THE CUSTOMER REPORTED THAT THE PATIENT REQUIRED A BLOOD TRANSFUSION THE NEXT DAY. IT IS NOT KNOWN WHETHER THE TRANSFUSION WAS RELATED TO THIS EVENT. NEW SYSTEMS WERE SETUP AND THE INFUSIONS CONTINUED. NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345583 ALARIS PUMP MODULE ADMINISTRATION SET IV INFUSION SET FPA CAREFUSION CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ADD ON FILTER & BLUE NEEDLELESS CONNECTOR,| CAREFUSION, BURETTE SET, MODEL/LOT UNK| SMITHS MEDICAL ASD, EXTENSION SET, MODEL/LOT UNK| IV CATHETER, MFR/MODEL/LOT UNK,| ALARIS PC UNIT & 2X PUMP MODULES SNS UNKNOWN,| MFR/MODEL/LOT UNK| BBRAUN, STOPCOCK, MODEL/LOT UNK,