BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1633093 · Received March 17, 2010

    Report

    Report Number
    6000001-2010-00320
    Event Type
    Malfunction
    Date Received
    March 17, 2010
    Date of Event
    January 11, 2010
    Report Date
    March 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT INTENDED TO BE SENT TO BAXTER FOR REPAIR - THE FACILITY HAS SENT THE DEVICE TO (B)(6) HOSPITAL SERVICES. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THROUGH A VOLUNTARY MEDWATCH THAT WAS FORWARDED TO BAXTER HEALTHCARE, A FACILITY REPRESENTATIVE REPORTED A PUMP WITH A BACKFLOW PROBLEM - THE "RIDER" BAG OF POTASSIUM (KCL) "BACKED UP INTO THE D5NS [SALINE]". THE PATIENT WAS TO BE INFUSED WITH A SECONDARY BAG OF POTASSIUM (KSL), AND A PRIMARY OF SALINE (D5NS), AT A RATE OF 83 CC/HR . THIS PROBLEM WAS IDENTIFIED DURING PATIENT USE ON A (B)(6) MALE. THERE WAS NO REPORT OF PATIENT INJURY, ADVERSE EVENT OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THE BAGS, SETS, AND DEVICE WERE SWAPPED FOR REPLACEMENTS, AND INFUSION WAS COMPLETED WITHOUT FURTHER INCIDENT. THE SOFTWARE VERSION IS NOT CURRENTLY AVAILABLE FOR THIS DEVICE.NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR