BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA MODEL SPECTRUM

    MDR report key: 1891351 · Received October 22, 2010

    Report

    Report Number
    1314492-2010-00022
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 22, 2010
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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

    ON FRIDAY AFTERNOON, (B)(6), A NURSE WAS INFUSING ALTEPLASE AT A RATE OF 25ML PER HOUR, VTBI WAS 50ML AS WAS THE BAG SIZE. THE NURSE HAPPENED TO BE WALKING BY TEN MINS LATER AND COULD HEAR THE PUMP MOTOR AT FULL SPEED. UPON INSPECTION SHE REALIZED THE BAG WAS ALMOST EMPTY. SHE PROCEEDED TO REMOVE THE PUMP AND REPLACE IT WITH ANOTHER ((B)(4)), ONLY TO FIND THE SAME RESULTS. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA MODEL SPECTRUM SPECTRUM INFUSION PUMP FRN SIGMA LLC 35700 759556

    Patients

    Seq Age Sex Outcome Treatment
    1