BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1832725 · Received September 13, 2010

    Report

    Report Number
    6000001-2007-00799
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    December 14, 2006
    Report Date
    December 14, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS EVALUATED AT A BAXTER SERVICE CENTER. THE REPORTED CONDITION OF FAILURE CODE 812:02 WAS CONFIRMED. THE PUMPHEAD MODULE WAS FOUND TO BE FUNCTIONING OUTSIDE OF SPECIFICATION WHICH CAUSED THE FAILURE TO OCCUR. THE PUMPHEAD MODULE WAS REPLACED AND THE DEVICE WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FROM CUSTOMER FOR SERVICE. DURING SERVICE BY BAXTER TECHNICIAN, THE DEVICE WAS FOUND TO HAVE FAILURE CODE 812:02 IN THE EVENT HISTORY. CUSTOMER REPORTED THERE WERE NO PATIENT INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

    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