BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1231104 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88292
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    April 1, 2007
    Report Date
    April 27, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE.LTD
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Removal / Correction Number
    2006-0028-MD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: FAILURE CODE 810:04, AN AIR SENSOR FAILURE, WAS INITIALLY REPORTED BY THE FACILITY. IT WAS UNKNOWN WHEN THE EVENT OCCURRED.EVALUATION SUMMARY:THE CONDITION OF THE AIR-IN-LINE PRINTED CIRCUIT BOARD OUT-OF-SPECIFICATION WAS CONFIRMED DURING TESTING. THE AIR-IN-LINE PRINTED CIRCUIT BOARD WAS RECALIBRATED. FAILURE CODE 814:04, REPORTED BY THE CUSTOMER, WAS CONFIRMED. THE PUMP WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL.

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER, THE INFUSION PUMP WAS FOUND TO CONTAIN AN AIR-IN-LINE SENSOR THAT WAS OUT-OF-SPECIFICATION. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OF MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE.LTD

    Patients

    Seq Age Sex Outcome Treatment
    1