BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA MODEL SPECTRUM

    MDR report key: 1891371 · Received October 19, 2010

    Report

    Report Number
    1314492-2010-00020
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 19, 2010
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A F/U REPORT WILL BE SUBMITTED, ONCE A FULL EVAL HAS BEEN CONDUCTED BY SIGMA ENGINEERING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SIGMA SPECTRUM INFUSION PUMP THAT WAS PROGRAMMED TO INFUSE DOPAMINE FOR A PT WEIGHING (B)(6) INSTEAD OF (B)(6). THE CUSTOMER ALSO STATED THAT THE SPECTRUM PUMP WAS SUPPOSED TO HAVE AN UPPER WEIGHT LIMIT OF (B)(6) BUT WHEN HE TRIED IT ON HIS DEMO DEVICE THE DEVICE ACCEPTED A PT WEIGHT OF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA MODEL SPECTRUM SPECTRUM INFUSION PUMP FRN SIGMA LLC 35700 766975

    Patients

    Seq Age Sex Outcome Treatment
    1