BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURBISHED COLLEAGUE VOLUMETRIC INFUSOR

    MDR report key: 1240224 · Received November 24, 2008

    Report

    Report Number
    6000001-2007-06279
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    April 1, 2007
    Report Date
    April 12, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DURING PRODUCT EVALUATION, THE AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB) VALUES WERE FOUND TO BE OUT OF CALIBRATION. FAILURE CODE 810:04 IN THE EVENT HISTORY CONFIRMS THE DEFECTIVE AIL PCB. THIS FAILURE CODE IS MANIFESTED AS A RESULT OF THE AIL PCB BEING OUT OF CALIBRATION. THE AIL PCB WAS RECALIBRATED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH A FAILURE CODE 810:04 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 REFURBISHED COLLEAGUE VOLUMETRIC INFUSOR INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1