BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM PUMP

    MDR report key: 1953610 · Received January 5, 2011

    Report

    Report Number
    MW5018887
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    December 17, 1955
    Report Date
    December 30, 2010
    Manufacturer
    SIGMA, LLC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN OUTPATIENT HEMATOLOGY/ONCOLOGY UNIT RECEIVING REMICADE VIA SIGMA SPECTRUM INFUSION PUMP. THE PT WAS IN A RECLINER CHAIR. THE PT'S WIFE CAME TO VISIT HIM, SHE TOOK OFF HER JACKET AND TOUCHED HIS ARM. THERE WAS A SPARK. THE NURSE CARING FOR THE PT REPORTS THAT ABOUT 1 MINUTE LATER, THE "PUMP MADE NOISE WE NEVER HEARD BEFORE" AND STOPPED WORKING. THE NURSE WAS NOT ABLE TO TURN THE PUMP ON AND IT CONTINUED TO MAKE A BEEPING SOUND. THE PUMP WAS REMOVED FROM SERVICE. NEITHER THE PT OR HIS WIFE SUSTAINED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA SPECTRUM PUMP SIGMA SMART PUMP FRN SIGMA, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Other BAXTER IV TUBING