BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1241628 · Received November 25, 2008

    Report

    Report Number
    6000001-2007-04544
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 16, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-7/20/05015-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF FAIL CODE 804:22 WAS CONFIRMED. THIS FAILURE IS ASSOCIATED WITH THE USER INTERFACE MODULE COMMUNICATION WITH THE PUMP HEAD MODULE. THE PUMP HEAD MODULE WAS REPLACED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FAIL CODE 804:22. THE HOSPITAL REPRESENTATIVE DID NOT HAVE INFORMATION REGARDING WHETHER THERE HAVE BEEN ANY REPORTS OF ANY PATIENT INJURY OR MEDICAL INTERVENTION. 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