BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1240381 · Received November 25, 2008

    Report

    Report Number
    6000001-2007-04388
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 12, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED A PUMP WITH A BAD UIM BOARD. THIS OCCURRED DURING BIO-MED TESTING EVALUATION SUMMARY: THE CONDITION OF A DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD (UIM PCB) WAS CONFIRMED. FAILURE CODE 403 IN THE EVENT HISTORY CONFIRMS THE DEFECTIVE UIM PCB. THIS FAILURE CODE IS 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 UNDER CAPA.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION, THE PUMP¿S USER INTERFACE MODULE PRINTED CIRCUIT BOARD (UIM PCB) WAS FOUND TO BE DEFECTIVE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1