BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1240202 · Received November 24, 2008

    Report

    Report Number
    6000001-2007-05958
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    April 1, 2007
    Report Date
    April 11, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED A PUMP WITH FAILURE CODE 810:13. THIS OCCURRED DURING BIO-MED TESTING. EVALUATION SUMMARY: THE CONDITION OF THE AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB) VALUES BEING OUT OF SPECIFICATION WERE CONFIRMED. FAILURE CODE 810:13 WAS MAMIFESTED AS A RESULT OF THIS CONDITION. THE AIL PCB WAS REPLACED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION, THE PUMP'S AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB) WAS FOUND TO BE OUT OF SPECIFICATION. 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