BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1163636 · Received September 19, 2008

    Report

    Report Number
    6000001-2007-05271
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    October 9, 2006
    Report Date
    October 9, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    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 FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON MAR 28 2007. EVALUATION SUMMARY:THE CONDITION OF THE PUMP'S AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB) BEING OUT OF SPECIFICATION WAS CONFIRMED. THIS PART 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