BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1173687 · Received September 25, 2008

    Report

    Report Number
    6000001-2007-05347
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    March 1, 2007
    Report Date
    March 3, 2007
    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
    NC, 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 30 2007. ADDITIONAL INFORMATION:FAILURE CODE 810:11 WAS INITIALLY REPORTED BY THE FACILITY. IT IS UNKNOWN WHEN THIS MESSAGE OCCURRED. EVALUATION SUMMARY: DURING PRODUCT EVALUATION FAILURE CODE 810:11 WAS CONFIRMED AND WAS ATTRIBUTED TO THE AIR-IN LINE PRINTED CIRCUIT BOARD WHICH WAS CONFIRMED TO BE OUT-OF-SPECIFICATION. THE AIR-IN LINE PRINTED CIRCUIT BOARD WAS RECALIBRATED. THE PUMP WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL.

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1