BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1160301 · Received September 16, 2008

    Report

    Report Number
    6000001-2007-03471
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 12, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 30 2007. EVALUATION SUMMARY:THE MAIN BATTERIES ISSUE WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THE PUMP'S BATTERIES WERE DEPLETED. FURTHER INVESTIGATION FOUND FAILURE CODE 570 IN THE EVENT HISTORY WHICH WAS CAUSED BY LOW VOLTAGE FROM THE DEPLETED BATTERIES. DURING EVALUATION, THE BATTERY HISTORY WAS FOUND TO CONTAIN 5 BATTERY DISCHARGES BELOW THE ALARM THRESHOLD WHICH INDICATED THAT THE BATTERIES WERE DISCHARGED TO A POTENTIALLY DAMAGING LEVEL AND WERE THEREFORE REPLACED. 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 FACILITY REPORTED AN INFUSION PUMP WITH AN ISSUE WITH THE MAIN BATTERIES. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING BIOMED TESTING. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1