BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1212424 · Received October 29, 2008

    Report

    Report Number
    6000001-2007-98822
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    July 3, 2007
    Report Date
    July 3, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JULY 12, 2007. THE FACILITY REPORTED A PUMP WITH FAILURE CODE 810:11. IT IS UNKNOWN WHEN THIS FAILURE CODE OCCURRED. EVALUATION SUMMARY: THE CONDITION OF AN AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB) BEING OUT OF SPECIFICATION WAS CONFIRMED. FAILURE CODE 810:11 WAS MANIFESTED AS A RESULT OF THIS CONDITION. THE AIL PCB WAS RECALIBRATED ON THE PUMP TO CORRECT THIS FAILURE.

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1