BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1183687 · Received October 4, 2008

    Report

    Report Number
    6000001-2007-00578
    Event Type
    Malfunction
    Date Received
    October 4, 2008
    Date of Event
    December 13, 2006
    Report Date
    December 13, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 05, 2007. EVALUATION SUMMARY: THE REPORTED CONDITION OF DEPLETED BATTERIES WAS CONFIRMED. THE BATTERIES WERE REPLACED DUE TO POTENTIAL DAMAGE. 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, THE BAXTER REPAIR TECHNICIAN REPORTED DEPLETED BATTERIES. THE HOSPITAL REPRESENTATIVE STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INCIDENT INVOLVING THIS PUMP. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1