BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1160329 · Received September 16, 2008

    Report

    Report Number
    6000001-2007-01819
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    December 27, 2006
    Report Date
    December 27, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE LTD
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CONDITION OF DEPLETED BATTERIES WAS CONFIRMED. THE MAIN BATTERIES WERE REPLACED DUE TO POTENTIAL DAMAGE. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS CURRENTLY BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    BATTERIES THE FACILITY RETURNED THE DEVICE FOR SERVICE. DURING SERVICE THE BAXTER REPAIR TECHNICIAN NOTED DEPLETED BATTERIES. 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 COLLEAGUE VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1