BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1236491 · Received November 20, 2008

    Report

    Report Number
    6000001-2007-04454
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 19, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF THE OVER INFUSION ON CHANNELS A, B AND C WAS CONFIRMED DURING PRODUCT EVALUATION. INSPECTION OF THE DEVICE FOUND THAT THE OVER INFUSION ON CHANNEL A WAS CAUSED B DEBRIS FOUND IN THE PUMP HEAD MECHANISM CHANNEL. THIS PUMP HEAD MECHANISM CHANNEL WAS CLEANED. INSPECTION OF THE DEVICE ALSO FOUND THAT THE OVER INFUSION ON CHANNEL B AND C WAS CAUSED CRACKED EPOXY IN THE PUMP HEAD MECHANISMS. THE EPOXY WAS REAPPLIED ON THE PUMP HEAD MECHANISMS BAND C.

    Description of Event or Problem · 1

    THE FACILITY REPORTS A PUMP THAT OVER INFUSED ON CHANNELS A, B AND C. THIS PROBLEM WAS IDENTIFIED DURING BIO-MED TESTING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION WAS 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