BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1023178 · Received April 4, 2008

    Report

    Report Number
    6000001-2007-00931
    Event Type
    Malfunction
    Date Received
    April 4, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 11, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE EVALUATION WAS COMPLETED AND FAILURE CODE 500 CONFIRMED (KEYPAD TEST FAILED #8) DUE TO A DEFECTIVE FRONT BEZEL. SERVICE INSTALLED NEW FRONT BEZEL AND TESTED THE DEVICE. A REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT AND THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A PUMP WITH FAILURE CODE 500 (KEYPAD TEST FAILED FOR #8). THE CONDITION WAS DISCOVERED DURING BIO-MED TESTING. ACCORDING TO THE HOSPITAL REPRESENTATIVE, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1