BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SE PUMP

    MDR report key: 3230024 · Received July 10, 2013

    Report

    Report Number
    2016493-2013-00307
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 22, 2013
    Report Date
    July 4, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K063288
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THE CUSTOMER HAS INDICATED THE DEVICES WILL BE RETURNED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A HEPARIN OVER INFUSION. HEPARIN 25,000 UNITS IN 500ML OF D5W WAS STARTED AT MIDNIGHT AND BY 0300 THE BAG WAS ALMOST EMPTY. THE RATE OF INFUSION WAS 32 ML/HR. THE PUMP WAS TURNED OFF AT 0320. THE PATIENT REQUIRED ADDITIONAL TREATMENT AND TESTING (SPECIFIC DETAILS NOT AVAILABLE). TESTING BY THE CUSTOMER DETERMINED A 6-8% DISCREPANCY IN FLOW RATE. THE CUSTOMER STATED THE IV SET WILL BE SENT IN WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316004 ALARIS SE PUMP FRN CAREFUSION CORPORATION 7230 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS SE PUMP ADMIN IV SET: MODEL #UNK, LOT #UNK