BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1832702 · Received September 13, 2010

    Report

    Report Number
    6000001-2007-00419
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    December 12, 2006
    Report Date
    December 12, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-7/20/05-015-C
    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 (B)(4), 2007. EVALUATION SUMMARY: THE DEVICE EVALUATION WAS COMPLETED AND FAILURE CODE 703 WAS CONFIRMED (FOUND IN EVENT HISTORY) DUE TO DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD (UIM PCB). SERVICE INSTALLED A NEW UIM PCB AND TESTED THE DEVICE. A REVIEW OF THE COMPLAINT HISTORY REVEALED SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT AND THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA, (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED FOR SERVICE. DURING SERVICE TESTING, FAILURE CODE 703 WAS FOUND IN THE EVENT HISTORY. 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 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1