BEUDAMED
    FDA Adverse Event Other Summary report: N

    PCA II PUMP 2L3104

    MDR report key: 632064 · Received August 24, 2005

    Report

    Report Number
    632064
    Event Type
    Other
    Date Received
    August 24, 2005
    Date of Event
    July 27, 2005
    Report Date
    August 23, 2005
    Manufacturer
    BAXTER HEALTHCARE INFUSION SYSTEMS
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    ON THE NURSING UNIT, A PATIENT CONTROLLED ANALGESIC (PCA) PUMP INFUSING MEDICATION INTO A PATIENT WENT INTO A FAULT CONDITION.. THE PUMP IS A BAXTER PCAA II, THE ATTENDING NURSE REMOVED THE UNIT FROM THE PATIENT AND REPLACED IT WITH ANOTHER OF THE SAME TYPE. THERE WERE NO FURTHER PROBLEMS WITH THIS PATIENT, NOR THE REPLACEMENT UNIT. THE BROKEN UNIT WAS SENT BACK TO THE MANUFACTURER FOR WARRANTY REPAIR. THEY REPLACED A BROKEN COVER, SENT THE UNIT BACK TO US AND IT WAS RETURNED TO SERVICE. THE PATIENT WAS NOT HARMED BY THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA II PUMP 2L3104 PATIENT CONTROLLED ANALGESIC PUMP MEA BAXTER HEALTHCARE INFUSION SYSTEMS PCA II *

    Patients

    Seq Age Sex Outcome Treatment
    1 *