BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1173648 · Received September 25, 2008

    Report

    Report Number
    6000001-2007-05567
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    March 1, 2007
    Report Date
    March 2, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 APR 12, 2007. THE FACILITY REPORTED A PUMP WITH FAILURE CODE 810:04. IT IS UNKNOWN WHEN THIS OCCURRED. EVALUATION SUMMARY:DURING PRODUCT EVALUATION, THE AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB) VALUES WERE FOUND TO BE OUT OF SPECIFICATION. FAILURE CODE 810:04 WAS MANIFESTED AS A RESULT OF THIS CONDITION. THE AIL PCB WAS RECALIBRATED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION, THE PUMP'S AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB) WAS FOUND TO BE OUT OF SPECIFICATION. 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 CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1