BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 746153 · Received October 13, 2005

    Report

    Report Number
    6000001-2005-05013
    Event Type
    Malfunction
    Date Received
    October 13, 2005
    Date of Event
    September 1, 2005
    Report Date
    September 19, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS COMPLETED AND THE REPORTED CONDITION OF THE FAILURE CODE 570:320:844:000 WAS CONFIRMED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED.

    Description of Event or Problem · 1

    A FAILURE CODE 570:320:844:0000. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING BIOMED TESTING. THE HOSPITAL REPRESENTATIVE 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. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING PATIENT'S DEMOGRAPHICS, MEDICATION INVOLVED, OR DEVICE PROGRAMMING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN