BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1024105 · Received April 5, 2008

    Report

    Report Number
    6000001-2007-04695
    Event Type
    Malfunction
    Date Received
    April 5, 2008
    Date of Event
    January 1, 2007
    Report Date
    February 14, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION WAS COMPLETED AND THE CUSTOMER'S REPORTED CONDITION OF "BROKEN" WAS CONFIRMED. DURING INSPECTION OF THE DEVICE, THE USER INTERFACE MODULE PRINTER CIRCUIT BOARD (UIM PCB) WAS FOUND TO BE OUT OF SPECIFICATION RESULTING IN FAILURE CODES 702, 703, 403, AND 533. THE UIM PCB WAS REPLACED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN INFUSION PUMP "BROKEN." INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE DEVICE WAS IN PATIENT USE WHEN THE EVENT OCCURRED. THE HOSPITAL REPRESENTATIVE STATED THAT THEY HAVE NO RECORD OF ANY PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING PATIENT'S DEMOGRAPHICS, MEDICATION INVOLVED, OR DEVICE PROGRAMMING. NO ADDITIONAL CONTACT INFORMATION WAS AVAILABLE. DURING EVALUATION, THE USER INTERFACE MODULE PRINTER CIRCUIT BOARD (UIM PCB) WAS FOUND TO BE OUT OF SPECIFICATION AND ASSOCIATED WITH FAILURE CODES 702:00, 703:00, 403:317, AND 533:320.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1