BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1023096 · Received April 3, 2008

    Report

    Report Number
    6000001-2007-00345
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 8, 2006
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE INFUSION PUMP WAS TESTED FOR FLOW ACCURACY AT 100 ML/HOUR, THE INFUSION PUMP FAILED THE ACCURACY TEST. THE SPECIFICATION OF THIS DEVICE IS +/-5%. THE CONDITION OF ACCURACY TEST FAILURE WAS CONFIRMED ON SITE AT THE CUSTOMER LOCATION BY A FIELD SERVICE ENGINEER. THE PUMP HEAD MODULE WAS REPLACED. SERVICE OF THE DEVICE WAS CONDUCTED ON-SITE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED THAT THE DEVICE FAILED ACCURACY TESTING. THE EVENT OCCURED DURING BIO-MED TESTING. THE DEVICE WAS SERVICED ON SITE AT THE CUSTOMER'S LOCATION BY A FIELD SERVICE ENGINEER. THE FACILITY REPRESENTATIVE STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS INCIDENT. ADDITIONAL CONTACT INFORMATION WAS NOT AVAILABLE. NO ADDITIONAL INFORMATION IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1