BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1183589 · Received October 4, 2008

    Report

    Report Number
    6000001-2007-00287
    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
    NY, 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 08, 2007. EVALUATION SUMMARY: THE CONDITION OF FAIL CODE 814:01 WAS CONFIRMED. THIS FAIL CODE WAS ASSOCIATED WITH BATTERIES. INSPECTION OF THE DEVICE FOUND THAT THE MAIN BATTERIES WERE DEPLETED AND POTENTIALLY DAMAGED. THE MAIN BATTERIES WERE REPLACED DURING SERVICE. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. FAILURE CODE 814:01 IS CURRENTLY BEING INVESTIGATED. BATTERY ISSUE IS CURRENTLY BEING INVESTIGATED.

    Description of Event or Problem · 1

    THE FACILITY RETURNED THE DEVICE FOR SERVICE. DURING PRODUCT EVALUATION, THE BAXTER REPAIR TECHNICIAN FOUND A FAIL CODE 814:01 IN THE EVENT HISTORY. 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 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1