BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS 50 INFUSION PUMP

    MDR report key: 1230443 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88600
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    June 21, 2007
    Report Date
    June 25, 2007
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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

    CUSTOMER REPORTED AN AS50 PUMP WAS PROGRAMMED TO ADMINISTER LIPIDS TO A FEMALE NICU PATIENT. PUMP WAS PROGRAMMMED TO ADMINISTER LIPIDS AT A RATE OF 1.4M/HOUR. TOTAL OF 17 ML OVER A 12 HOUR PERIOD OT TIME. SYRINGE CONTAINED 30CC OF LIPIDS. PUMP ALARMED AFTER 30 MINUTES INTO TREATMENT AND 5CC OF LIPIDS WERE LEFT IN SYRINGE. A BLOOD TEST WAS PERFORMED ON THE PATIENT. FACILITY ADDED ADDITIONAL STAFFING HOURS TO MONITOR THE PATIENT AFTER THIS INCIDENT OCCURRED. PATIENT HAS BEEN REPORTED TO BE FINE. NO THERAPY WAS ADMINISTERED TO THE PATIENT AS A RESULT OF THE ADDITIONAL LIPIDS RECEIVED BY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AS 50 INFUSION PUMP 80FPA FPA BAXTER HEALTHCARE N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1