BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1160376 · Received September 16, 2008

    Report

    Report Number
    6000001-2007-04747
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    February 15, 2007
    Report Date
    February 15, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 MAR 01 2007. DURING PRODUCT EVALUATION, THE AIR IN LINE PRINTED CIRCUIT BOARD VALUES WERE FOUND TO BE OUT OF SPECIFICATION (AIL PCB). THE AIL PCB WAS REPLACED. AFTER THE AIL PCB WAS REPLACED IT WAS STILL OUT OF SPECIFICTION SO THE PUMP HEAD MODULE WAS REPLACED.

    Description of Event or Problem · 1

    THE FACILITY RETURNED THE DEVICE FOR SERVICE. DURING SERVICE THE BAXTER REPAIR TECHNICIAN NOTED THAT THE AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB) WAS OUT OF CALIBRATION. THE HOSPITAL REPRESENTATIVE STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INCIDENT INVOLVING THIS PUMP. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1