BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1193245 · Received October 14, 2008

    Report

    Report Number
    6000001-2007-03966
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 8, 2007
    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 FEB 02, 2007. EVALUATION SUMMARY: THE DEVICE EVALUATION WAS COMPLETED AND THE FAILURE CODE 814:04 WAS CONFIRMED DUE TO A DEFECTIVE PUMP HEAD MODULE. SERVICE REPLACED THE PHM AND TESTED THE DEVICE. A REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A PUMP WITH FAILURE CODE OF 814:04. THE CONDITION OCCURRED DURING BIO-MED TESTING. ACCORDING TO THE HOSPITAL REPRESENTATIVE THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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