BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1231475 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-05364
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    February 21, 2007
    Report Date
    March 12, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE.LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION WAS PERFORMED AND THE REPORTED CONDITION OF FAILURE CODE 810:11 WAS CONFIRMED IN THE EVENT HISTORY BUT COULD NOT BE DUPLICATED. INSPECTION OF THE PUMP REVEALED AIR IN LINE PRINTER CIRCUIT BOARD (AIL PCB) WAS WITHIN SPECIFICATION. THE FAILURE CODE 810:11 COULD HAVE BEEN DUE TO WET TUBING, NO REPAIR NEEDED. THE PUMP WAS TESTED FOR PROPER OPERATION AND PUMP FOUND TO FUNCTION PROPERLY.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH A FAILURE CODE 810:11. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING PATIENT INFUSION IN 2007. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OF CONTACT WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1