BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2713200 · Received August 17, 2012

    Report

    Report Number
    1314492-2012-00220
    Event Type
    Malfunction
    Date Received
    August 17, 2012
    Date of Event
    July 19, 2012
    Report Date
    July 20, 2012
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION AND WAS UNABLE TO REPRODUCE A SYSTEM ERROR 345. THE PUMP WAS TESTED FOR 24 HRS WITH NO OCCURRENCE OF SYSTEM ERROR 345. REVIEW OF THE DEVICE HISTORY LOG SHOWS 2 OCCURRENCES OF A SYSTEM ERROR 345 ON THE REPORTED DAY OF THE EVENT. THE CUSTOMER STATED THAT THE DEVICE WAS IN USE IN THE FACILITY'S CATHETERIZATION LABORATORY, THE TEMPERATURE RANGE IN THAT CARE AREA IS 55-59 DEGREES F, WHICH IS INCONSISTENT WITH THE DEVICE'S LOWER OPERATING TEMPERATURE SPECIFICATION OF 60 DEGREES F. A SYSTEM ERROR 345 OCCURS WHEN THE TEMPERATURE REPORTED BY THE UPSTREAM AND DOWNSTREAM THERMISTORS HAVE A DIFFERENCE OF GREATER THAN 10 DEGREES FAHRENHEIT FOR 10 CONSECUTIVE CAM REVOLUTIONS. SIGMA'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP ALARMED FOR A SYSTEM ERROR 345. THE ALARM OCCURRED PRIOR TO DELIVERING ANGIOMAX TO A PT. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1