BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1943046 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06483
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE TO BAXTER FOR EVALUATION. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT A COLLEAGUE INFUSION PUMP THAT HAD A MALFUNCTION. THE CUSTOMER STATED THAT THE HEPARIN WAS SET AT THE DOSE OF 1,600 UNITS/HOUR. THIS SHOULD HAVE EQUALED 16.5 CUBIC CENTIMETERS/HOUR, BUT INSTEAD AFTER HALF HOUR OF INFUSION THE PUMP WAS FOUND TO BE RUNNING AT 0.2 CUBIC CENTIMETERS/HOUR. THE NURSE MANUALLY ADJUSTED THE RATE TO 16.5 CUBIC CENTIMETERS AND THE PUMP HAS BEEN INFUSING FINE SINCE THEN. PATIENT MISSED HALF AN HOUR OF HEPARIN TREATMENT. THE PATIENT RECOVERED. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS CURRENTLY UNKNOWN FOR THIS DEVICE.

    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 HEPARIN