BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1171024 · Received September 24, 2008

    Report

    Report Number
    6000001-2007-02150
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    January 10, 2007
    Report Date
    January 10, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON JAN 19 2007. EVALUATION SUMMARY: THE REPORTED CONDITION OF DEPLETED BATTERIES WAS CONFIRMED BY THE BAXTER REPAIR TECHNICIAN. INSPECTION OF THE DEVICE REVEALED POTENTIALLY DEPLETED MAIN BATTERIES, WHICH WERE REPLACED. THE DEVICE WAS TESTED BY THE REPAIR TECHNICIAN. THE NEW STYLE BATTERY HARNESS WAS ALSO INSTALLED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR SERVICE. DURING SEVICE TESTING, THE BAXTER TECHNICIAN REPORTED AN INFUSION PUMP WITH DEPLETED BATTERIES. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL INFORMATION IS KNOWN.

    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