BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1170207 · Received September 24, 2008

    Report

    Report Number
    6000001-2007-02343
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    December 29, 2006
    Report Date
    December 29, 2006
    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

    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 22 2007. EVALUATION SUMMARY: EVALUATION WAS PERFORMED AND THE CONDITION WAS CONFIRMED BY THE BAXTER REPAIR TECHNICIAN. INSPECTION OF THE PUMP REVEALED DEPLETED MAIN BATTERIES. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED BY THE REPAIR TECHNICIAN. THE PUMP WAS TESTED FOR PROPER OPERATION AND PUMP WAS FOUND TO FUNCTION PROPERLY. 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 RETURNED THE DEVICE FOR SERVICE. DURING SERVICE TESTING, THE BAXTER REPAIR TECHNICIAN REPORTED AN INFUSION PUMP WITH DEPLETED MAIN BATTERIES. THE HOSPITAL REPRESENTATIVE STATED THEY HAVE NO RECORD OF ANY PATIENT INJURY OR MEDICAL INTERVENTION WITH THIS DEVICE. NO ADDITIONAL INFORMATION IS KNOWN.

    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