BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPUMP PAIN MANAGEMENT SYSTEM

    MDR report key: 431006 · Received November 27, 2002

    Report

    Report Number
    6000001-2002-05625
    Event Type
    Malfunction
    Date Received
    November 27, 2002
    Date of Event
    November 1, 2002
    Report Date
    November 4, 2002
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED AN INFUSION PUMP WITH FAILURE CODE 33. ALTHOUGH ATTEMPTS WERE MADE BY BAXTER TO OBTAIN ADDITIONAL INFORMAITION FROM THE REPORTING FACILITY, DETAILS WERE NOT AVAILABLE REGARDING PATIENT STATUS, MEDICAL INTERVENTION, PATIENT INJURY, AGE OF PATIENT, MEDICATION INVOLVED OR THE SET UP OF THE INFUSION DEVICE. THE HOSPITAL REPRESENTATIVE STATED THEY HAVE NO RECORD OF ANY PATIENT INCIDENT INVOLVING THE PUMP SINCE THE LAST BAXTER SERVICE EVENT. NO ADDITIONAL CONTACT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPUMP PAIN MANAGEMENT SYSTEM PCA PUMP MEA BAXTER HEALTHCARE (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN