BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1023028 · Received April 3, 2008

    Report

    Report Number
    6000001-2007-04097
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    July 5, 2006
    Report Date
    July 5, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION WAS COMPLETED AND THE REPORTED CONDITION OF DEPLETED MAIN BATTERIES WAS CONFIRMED. INSPECTION OF THE DEVICE REVEALED POTENTIALLY DAMAGED BATTERIES. THE MAIN BATTERIES WERE REPLACED AND THE BAXTER TECHNICIAN TESTED THE DEVICE. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE BY BAXTER, DEPLETED MAIN BATTERIES WERE FOUND. 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1