BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1212370 · Received October 29, 2008

    Report

    Report Number
    6000001-2007-81012
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    June 1, 2007
    Report Date
    June 14, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Removal / Correction Number
    2006-0028-MD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 27, 2007. ADDITIONAL INFORMATION:FAILURE CODE 810:11 WAS INITIALLY REPORTED BY THE FACILITY. IT WAS REPORTED TO HAVE OCCURRED DURING BIOMED TESTING. EVALUATION SUMMARY: THE CONDITION OF AIR-IN-LINE PRINTED CIRCUIT BOARD OUT-OF-CALIBRATION WAS CONFIRMED ON CHANNEL A DURING TESTING. THE FACILITY REPORTED CODE 810:11 WAS CONFIRMED IN THE EVENT HISTORY AND WAS PROBABLY GENERATED BECAUSE THE AIR-IN-LINE PRINTED CIRCUIT BOARD WAS OUT-OF-CALIBRATION. THE AIR-IN-LINE PRINTED CIRCUIT BOARD WAS RECALIBRATED.COMPLAINT NO: CMPLNT-000035488

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER, THE AIR-IN-LINE PRINTED CIRCUIT BOARD OF A COLLEAGUE PUMP WAS FOUND TO BE 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 3CX VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1