BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+

    MDR report key: 3062560 · Received April 10, 2013

    Report

    Report Number
    3062560
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 1, 2012
    Report Date
    April 10, 2013
    Manufacturer
    HOSPIRA INC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    WE HAVE BEEN HAVING PROBLEMS AT OUR FACILITY WITH PLUM A AND PLUM A+3 PUMPS (>200) INADEQUATELY PREVENTING FLUID FROM ENTERING THE DEVICE AND CAUSING DAMAGE TO THE PUMPING MECHANISM AND SENSORS. FLUID INGRESS COULD RESULT IN THE PUMP NOT RECOGNIZING THE CASSETTE. ERROR CODES N180, 181, 186, 187, 250, 251 AND 346 MAY BE DISPLAYED. NO PATIENT HARM HAS OCCURRED AND HOSPIRA TELLS US THEY WILL BE WORKING ON THE ISSUE IN THE 2ND QUARTER OF 2013. PROBLEM HAS BEEN OCCURRING FROM MARCH 2012 TO PRESENT. NO PATIENTS HAVE BEEN HARMED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?INFUSION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149612 PLUM A+ PUMP, INFUSION FRN HOSPIRA INC PLUM A+ *
    149613 PLUM A+ PUMP, INFUSION FRN HOSPIRA INC PLUM A+3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *