BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1193004 · Received October 13, 2008

    Report

    Report Number
    6000001-2007-03523
    Event Type
    Malfunction
    Date Received
    October 13, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 9, 2007
    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 JAN 30, 2007. EVALUATION SUMMARY: THE CUSTOMER REPORTED ISSUE WAS CONFIRMED DURING SERVICE. INSPECTION OF THE DEVICE FOUND THAT THE MAIN BATTERIES WERE DEPLETED WITH 19 BATTERY DISCHARGES BELOW ALARM THRESHOLD 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 CURRENTLY BEING INVESTIGATED UNDER CAPA.CONTINUED FROM H9:6000001-2/25/05-004-C6000001-12/13/05-019-CCONTINUED FROM D10:SERVICE OF THE DEVICE WAS CONDUCTED ON-SITE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN INFUSION PUMP WITH DEPLETED BATTERIES. THIS ISSUE REPORTED TO HAVE OCCURRED DURING BIO-MED TESTING. THE HOSPITAL REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1