BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1233176 · Received November 18, 2008

    Report

    Report Number
    6000001-2007-02908
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 4, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF A PUMP WITH DEPLETED BATTERIES WAS CONFIRMED DURING PRODUCT EVALUATION. INSPECTION OF THE DEVICE FOUND THAT THE PUMP¿S MAIN BATTERIES WERE FOUR DISCHARGES BELOW THE ALARM THRESHOLD. MAIN BATTERIES WERE DAMAGED AND THEREFORE THE BATTERIES WERE REPLACED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS CURRENTLY BEING INVESTIGATED. DEVICE WAS EVALUATED ON SITE IN EARLY 2007.

    Description of Event or Problem · 1

    THE FIELD SERVICE ENGINEER REPORTED A PUMP WITH DEPLETED BATTERIES. THIS PROBLEM WAS IDENTIFIED DURING BIO-MED TESTING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1