BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE DAY INFUSOR SYSTEM

    MDR report key: 360350 · Received November 2, 2001

    Report

    Report Number
    6000001-2001-00475
    Event Type
    Malfunction
    Date Received
    November 2, 2001
    Date of Event
    October 1, 2001
    Report Date
    October 4, 2001
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY THE INFUSORS (FOUR) ARE SUSPECTED OF OVERINFUSION SINCE IT WAS REPORTED THAT THE INFUSIONS WERE COMPLETED 11 HOURS EARLIER THAN ANTICIPATED. THE INFUSION INVOLVED MORPHINE (0.IG/ML) AND BUPIVICAINE 75MG IN SALINE DILUENT. THESE UNITS WERE ALSO REPORTED TO HAVE HAD LEAKAGE COMING FROM THE FILL PORTS DURING FILLING. NO PT ISSUES WERE REPORTED AS A RESULT OF THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49180 SINGLE DAY INFUSOR SYSTEM ELASTOMERIC INFUSION SYSTEM MEB BAXTER HEALTHCARE CORP NA 01G037

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN