BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1183603 · Received October 4, 2008

    Report

    Report Number
    6000001-2007-00182
    Event Type
    Malfunction
    Date Received
    October 4, 2008
    Date of Event
    December 8, 2006
    Report Date
    December 8, 2006
    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

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON JAN 03 2007. EVALUATION SUMMARY: FAILURE CODE 810:04 WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THIS FAILURE CODE WAS CAUSED BY THE PUMP'S AIR IN LINE PRINTED CIRCUIT BOARD BEING OUT OF SPECIFICATION. THIS PART WAS REPLACED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION, FAILURE CODE 810:04 WAS FOUND IN THE PUMP'S EVENT HISTORY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1