BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1172329 · Received September 25, 2008

    Report

    Report Number
    6000001-2007-03469
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    November 19, 2006
    Report Date
    January 2, 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

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON JAN 30 2007. EVALUATION SUMMARY: THIS DEVICE WAS NEVER ISOLATED AT THE CUSTOMER'S FACILITY FOR FURTHER EVALUATION. FACILITY HAS REPORTED THAT ADDITIONAL TRAINING HAS BEEN GIVEN TO THE TECHNICIAN TO ENSURE THAT THE SECONDARY (PIGGYBACK) IS HUNG HIGHER THAN THE PRIMARY AND THAT THE ROLLER CLAMPS ARE OPENED AND/OR CLOSED AS NEEDED TO ENSURE THE PROPER DELIVERY OF THERAPY. THIS USER ERROR IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THROUGH USER FACILITY REPORT, THAT CHEMOTHERAPY WAS BEING ADMINISTERED AS A SECONDARY (PIGGYBACK) IV (NORMAL SALINE PRIMARY). THE PATIENT'S FAMILY REPORTED TO NURSE THAT CHEMO BAG LOOKED VERY FULL. THE NURSE CHECKED THAT THE RATE WAS CORRECT AND DISCOVERED THAT THE ROLLER CLAMP ON THE SECONDARY WAS NOT COMPLETELY OPENED. CLAMP WAS OPENED AND NURSE NOTED A SLIGHT INCREASE IN FLOW. PATIENT WAS UNDER-DOSED BECAUSE OF THE EXPIRATION TIME OF CHEMOTHERAPY. ALTHOUGH REQUESTED, INFORMATION REGARDING THE PATIENT DEOMGRAPHICS WERE NOT 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