BEUDAMED
    FDA Adverse Event Summary report: N

    SPECTRUM

    MDR report key: 2010881 · Received February 17, 2011

    Report

    Report Number
    2010881
    Date Received
    February 17, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 17, 2011
    Manufacturer
    SIGMA
    Product Code
    FRN
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH FOUR IDENTICAL INFUSION PUMPS WAS RECEIVING CONTINUOUS CHEMOTHERAPY AT RATE OF 23ML/HR FROM ONE. DURING A SIX-HOUR PERIOD, PUMP APPEARED TO DELIVER 400ML. PUMP WAS REPLACED WITH ANOTHER. INTERROGATION OF THE PUMP IN QUESTION SHOWED THAT IT WAS PROGRAMMED DURING THAT SIX-HOUR PERIOD FOR DELIVERY OF A 300ML ANTIBIOTIC AS A SECONDARY AT A RATE OF 300ML/HR. THE ACTUAL ANTIBIOTIC WAS HUNG ON A DIFFERENT PUMP SO THE PUMP IN QUESTION INFUSED THE CHEMOTHERAPY AT THE SECONDARY RATE. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM INFUSION PUMP FRN SIGMA 35700 *
    2 BAXTER INTRAVASCULAR SET FPA BAXTER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR