BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1233123 · Received November 18, 2008

    Report

    Report Number
    6000001-2007-05967
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    April 1, 2007
    Report Date
    April 3, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH A FAILURE CODE 810:04 CONDITION. EVALUATION SUMMARY: DURING PRODUCT EVALUATION, A DEFECTIVE AIL (AIR IN LINE) PCB (PRINTED CIRCUIT BOARD) WAS OBSERVED. FAILURE CODE 810:04 AND 810:11 IN THE EVENT HISTORY CONFIRMS THE DEFECTIVE AIL PCB. THIS FAILURE CODE IS MANIFESTED AS A RESULT OF THE AIL PCB BEEN OUT OF CALIBRATION. THE AIL PCB WAS RECALIBRATED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR SERVICE. DURING TESTING, THE BAXTER TECHNICIAN REPORTED AN INFUSION PUMP WITH A DEFECTIVE AIL (AIR IN LINE) PCB (PRINTED CIRCUIT BOARD). ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAS BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL INFORMATION IS KNOWN.

    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