BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1212664 · Received October 29, 2008

    Report

    Report Number
    6000001-2007-88937
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    June 1, 2007
    Report Date
    June 1, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JULY 23, 2007. ADDITIONAL INFORMATION: FAILURE CODE 814:04 WAS INTIALLY REPORTED BY THE FACILITY. IT WAS UNKNOWN WHEN THE FAILURE CODE OCCURRED. EVALUATION SUMMARY: THE CONDITION OF AIR-IN-LINE PRINTED CIRCUIT BOARD OUT-OF-CALIBRATION WAS CONFIRMED DURING TESTING. THE AIR-IN-LINE PRINTED CIRCUIT BOARD WAS RECALIBRATED.

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER, THE INFUSION PUMP WAS FOUND TO CONTAIN AN AIR-IN-LINE PRINTED CIRCUIT BOARD THAT WAS OUT OF CALIBRATION. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1