BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURBISHED COLLEAGUE VOLUMETRIC INFUSOR

    MDR report key: 1161226 · Received September 17, 2008

    Report

    Report Number
    6000001-2007-04813
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    February 1, 2007
    Report Date
    February 6, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-7/20/05-015-C
    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 MAR 05 2007. ADDITIONAL INFORMATION:FAILURE CODE 703 WAS INITIALLY REPORTED BY THE FACILITY. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE DEVICE WAS IN PATIENT USE WHEN THE EVENT OCCURRED.EVALUATION SUMMARY: DURING PRODUCT EVALUATION, A DEFECTIVE USER INTERFACE MODULE WAS OBSERVED. FAILURE CODE 703 IN THE EVENT HISTORY CONFIRMS THE DEFECTIVE UIM. THIS FAILURE CODE IS MANIFESTED AS A RESULT OF THE UIM BEING DEFECTIVE. THE UIM WAS REPLACED. 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

    DURING SERVICE BY BAXTER, THE INFUSION PUMP WAS FOUND TO CONTAIN A DEFECTIVE USER INTERFACE MODULE. 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 REFURBISHED COLLEAGUE VOLUMETRIC INFUSOR INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1