BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1023155 · Received April 3, 2008

    Report

    Report Number
    6000001-2007-00506
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 11, 2006
    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
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE EVALUATION WAS COMPLETED AND FAILURE CODE 804:29 WAS CONFIRMED (IN EVENT HISTORY) DUE TO A DAMAGED USER INTERFACE INTERFACE MODULE PRINTED CIRCUIT BOARD (UIM PCB). SERVICE INSTALLED A NEW UIM PCB. A REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A PUMP WITH FAILURE CODE 804:29 (WILL NOT CLEAR) FOUND 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 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1