BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1233089 · Received November 18, 2008

    Report

    Report Number
    6000001-2007-05810
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    April 1, 2007
    Report Date
    April 2, 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

    THE FACILITY REPORTED FAILURE CODE 810:04. EVALUATION SUMMARY: DURING PRODUCT EVALUATION, AN OUT OF SPECIFICATION AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB) WAS CONFIRMED. THE REPORTED CONDITION OF FAILURE CODE 810:04 CONFIRMS THE OUT OF SPECIFICATION AIL PCB. THE AIL PCB WAS RECALIBRATED AND THE DEVICE WAS TESTED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION, AN OUT OF SPECIFICATION AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB) WAS OBSERVED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1