BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1212385 · Received October 29, 2008

    Report

    Report Number
    6000001-2007-88933
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    June 1, 2007
    Report Date
    June 26, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 23,2007. THE REPORTED CONDITION WAS NOT CONFIRMED. INSPECTION OF THE DEVICE SHOWED THE EVALUATION REPORT STATING THAT THIS PUMP WAS PERFORMING WELL WITHIN THE ESTABLISHED RANGE WHICH MEANS THAT THE PUMP WAS NOT OVER-INFUSING. HOWEVER THE EPOXY ON THE PUMP HEAD MODULE (PHM) WAS DAMAGED, SO THE PHM WAS REPLACED ON THE PUMP. THE PUMP WAS RE-EVALUATED, TESTED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP WITH OVER INFUSION BY THE PUMP HEAD MODULE (PHM). THE CONDITION OCCURRED DURING BIO-MED TESTING.

    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