BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1200971 · Received October 20, 2008

    Report

    Report Number
    6000001-2007-01796
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 7, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED 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 17, 2007. EVALUATION SUMMARY:EVALUATION WAS COMPLETED AND THE REPORTED CONDITION OF DEPLETED MAIN BATTERIES WAS CONFIRMED (FAILURE CODE 570 WAS FOUND IN THE EVENT HISTORY). INSPECTION OF THE DEVICE REVEALED DAMAGED BATTERIES. THE MAIN BATTERIES AND THE BATTERY HARNESS 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 UNDER CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INFUSION PUMP WITH A DEPLETED BATTERY CONDITION. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE FAILURE OCCURRED DURING AN INFUSION. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS 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