BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1234089 · Received November 19, 2008

    Report

    Report Number
    6000001-2007-03422
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 9, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY:FAILURE CODE 533:320 WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THE CAUSE OF THE FAILURE CODE WAS DUE TO A DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD AND SOFTWARE. THE USER INTERFACE MODULE PRINTED CIRCUIT BOARD AND SOFTWARE WERE 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 WHICH WAS OPENED ON JANUARY 28, 2005.CONTINUED FROM H9:6000001-2/25/05-004-C6000001-12/13/05-019-C

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO CUSTOMER SERVICE A PUMP WITH FAILURE CODE 533:320. THIS FAILURE CODE OCCURRED DURING BIO-MED TESTING. 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 CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1