BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1160332 · Received September 16, 2008

    Report

    Report Number
    6000001-2007-01036
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    January 2, 2007
    Report Date
    January 2, 2007
    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

    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 09 2007. EVALUATION SUMMARY:FAILURE CODE 814:01 WAS CONFIRMED. FAILURE CODE 814:01 OCCURS WHEN THE PUMP HEAD MODULE POWER SUPPLY IS TOO LOW. THIS CAN BE CAUSED WHEN THE PUMP IS LEFT IN THE BATTERY DEPLETED ALARM FOR AN EXTENDED PERIOD. INSPECTION OF THE PUMP DETERMINED THAT THE BATTERIES WERE DEPLETED AND POTENTIALLY DAMAGED AND THEY WERE THEREFORE REPLACED.REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE DEPLETED BATTERIES. THIS ISSUE IS BEING INVESTIGATED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR FAILURE CODE 814:01. THIS ISSUE IS BEING INVESTIGATED.

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER, THE INFUSION PUMP WAS FOUND TO CONTAIN FAILURE CODE 814:01. 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