BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1240410 · Received November 25, 2008

    Report

    Report Number
    6000001-2007-06112
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    April 1, 2007
    Report Date
    April 4, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    2005-047-MD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED AN INFUSION PUMP THAT READS FAILURE. EVALUATION SUMMARY: DURING PRODUCT EVALUATION, A DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD (UIM PCB) WAS OBSERVED. FAILURE CODE 703:00, 403:317:864:000, AND 402:317:858:000 IN THE EVENT HISTORY CONFIRMS THE DEFECTIVE UIM PCB. THESE FAILURE CODES ARE MANIFESTED AS A RESULT OF THE UIM PCB BEING DEFECTIVE. THE UIM PCB 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.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO BAXTER. DURING TESTING, THE BAXTER TECHNICIAN REPORTED AN INFUSION PUMP WITH A DEFECTIVE UIM (USER INTERFACE MODULE) PCB (PRINTED CIRCUIT BOARD). ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAS BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL INFORMATION IS KNOWN.

    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