BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSYRINGE INFUSION PUMP MODEL AS50

    MDR report key: 1233053 · Received November 18, 2008

    Report

    Report Number
    6000001-2007-05591
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    February 17, 2007
    Report Date
    March 29, 2007
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN REQUESTED FOR EVALUATION. IF DEVICE IS RECEIVED AND AN EVALUATION PERFORMED, A FOLLOW-UP MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    BAXTER CORPORATE PRODUCT SURVEILLANCE RECEIVED MAUDE EVENT REPORT FROM THE DEPARTMENT OF HEALTH & HUMAN SERVICES. DEPARTMENT OF HEALTH & HUMAN SERVICES RECEIVED A REPORT FROM THE CUSTOMER REGARDING THE BAXTER AS50 INFUSION PUMP. RISK MANAGER REPORTED PUMP WAS PROGRAMMED TO ADMINISTER INTRALIPID SOLUTION 20% TO A PREMIE NEWBORN MALE PATIENT, DOSE OF 8 ML/HOUR. TREATMENT STARTED AT 15:30. SYRINGE PUMP WAS CHECKED AT 16:30 AND IT WAS NOTED THAT PUMP HAD INFUSED 20ML OVER 1 HOUR OF THE 0.8 ML ORDERED. PATIENTS LIPID READING WAS 1200, NORMAL READING FOR INFANT IS 40. RISK MANAGER REPORTED NO ADDITIONAL TREATMENT WAS ADMINISTERED TO OFFSET THE HIGH LIPID READING. NO PATIENT INJURY OR MEDICAL INTERVENTION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSYRINGE INFUSION PUMP MODEL AS50 AUTO SYRINGE PUMPS FRN BAXTER HEALTHCARE (SG) N/A NA

    Patients

    Seq Age Sex Outcome Treatment
    1