BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1193233 · Received October 14, 2008

    Report

    Report Number
    6000001-2007-03867
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    January 11, 2007
    Report Date
    January 11, 2007
    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
    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 FEB 01, 2007. EVALUATION SUMMARY: THE CONDITION OF DAMAGED BATTERIES WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THE PUMP'S BATTERIES HAD MULTIPLE DISCHARGES BELOW THE ALARM THRESHOLD INDICATING THAT THE BATTERIES WERE DAMAGED. THE BATTERIES WERE REPLACED. 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

    DURING PRODUCT EVALUATION THE PUMP¿S BATTERIES WERE FOUND TO BE DAMAGED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1