BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE PUMP

    MDR report key: 450911 · Received April 1, 2003

    Report

    Report Number
    450911
    Event Type
    Injury
    Date Received
    April 1, 2003
    Date of Event
    March 16, 2003
    Report Date
    March 28, 2003
    Manufacturer
    BAXTER HEALTHCARE INC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFUSION SYRINGE PUMP DID NOT RECOGNIZE INPUT RATE OF 5.7CC/HR. RATE SET AS 57CC/HR. PT RECEIVED D10HAL-54CC IN 1 HR. ACCU CHECKS ELEVATED REQUIRING INSULIN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYRINGE PUMP INFUSION FRN BAXTER HEALTHCARE INC AS-50 *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DAY Required Intervention