BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURBISHED COLLEAGUE VOLUMETRIC INFUSOR

    MDR report key: 1023167 · Received April 3, 2008

    Report

    Report Number
    6000001-2007-02063
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    December 28, 2006
    Report Date
    December 28, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE LTD
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CONDITION OF FAIL CODE 570 WAS CONFIRMED. THIS FAIL CODE WAS CAUSED BY DEPLETED MAIN BATTERIES. THE MAIN BATTERIES 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.

    Description of Event or Problem · 1

    THE FACILITY RETURNED THE DEVICE FOR SERVICE. DURING SERVICE THE BAXTER REPAIR TECHNICIAN NOTED FAIL CODE 570. THE HOSPITAL REPRESENTATIVE STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INCIDENT INVOLVING THIS PUMP. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1