BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 652730 · Received December 7, 2005

    Report

    Report Number
    6000001-2005-07778
    Event Type
    Malfunction
    Date Received
    December 7, 2005
    Date of Event
    November 1, 2005
    Report Date
    November 9, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-7/20/05-015-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH ERROR 12:303:984:0002. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE DEVICE WAS IN PATIENT USE WHEN THE EVENT OCCURRED. THE HOSPITAL REP STATED THEY HAVE NO RECORD OF ANY PATIENT INCIDENT INVOLVING THE PUMP SINCE THE LAST BAXTER SERVICE EVENT AND NO PATIENT INJURY HAD BEEN REPORTED. NO ADDITIONAL CONTACT INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. COLLEAGUE 3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN