BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER

    MDR report key: 469533 · Received July 1, 2003

    Report

    Report Number
    MW1028874
    Event Type
    Malfunction
    Date Received
    July 1, 2003
    Date of Event
    June 11, 2003
    Report Date
    June 23, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ON PCA PUMP NEW SYRINGE AT 2500 AND PUMP SET AT 40 MGM/HR (2 MGM/CC). AT 0800 ONLY 5CC GONE FROM SYRINGE. SYRINGE SHOULD HAVE BEEN EMPTIED. PUMP SENT TO SITE BIOMED FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER PCA PUMP FRN BAXTER HEALTHCARE CORP. PCAII *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other