BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1190005 · Received October 8, 2008

    Report

    Report Number
    6000001-2007-02982
    Event Type
    Malfunction
    Date Received
    October 8, 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
    PA, US
    Reporter Occupation
    OTHER

    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 JAN 25, 2007. EVALUATION SUMMARY: THE DEVICE EVALUATION WAS COMPLETED AND THE DEPLETED BATTERY CONDITION WAS CONFIRMED DUE TO POTENTIALLY DAMAGED BATTERIES. BAXTER SERVICE TECHNICIAN INSTALLED NEW BATTERIES AND TESTED THE DEVICE. A 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. SERVICE WAS CONDUCTED ON-SITE.

    Description of Event or Problem · 1

    THE BAXTER FIELD SERVICE TECHNICIAN REPORTED A PUMP WITH LOW BATTERIES DURING BIO-MED TESTING. DEVICE WAS SERVICED ON-SITE. ACCORDING TO THE HOSPITAL REPRESENTATIVE THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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