BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM

    MDR report key: 3251587 · Received April 10, 2013

    Report

    Report Number
    3251587
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 1, 2012
    Report Date
    April 10, 2013
    Manufacturer
    HOSPIRA
    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 RECURRING PROBLEMS SINCE MARCH 2012 WITH PLUM A AND PLUM A+3 INFUSION PUMPS (MORE THAN 10 EVENTS). THE INFUSER FLUID SHIELD FLUID INGRESS MAY INADEQUATELY PREVENT FLUID FROM ENTERING THE DEVICE AND CAUSING DAMAGE TO THE PUMPING MECHANISM AND/OR SENSORS. FLUID INGRESS COULD ALSO RESULT IN THE PUMP NOT RECOGNIZING THE CASSETTE. ERROR CODES N180, 181, 186, 187, 250, 251, AND 346 MAY BE DISPLAYED. A DELAY OR INTERRUPTION COULD BE CAUSED. THERE HAVE BEEN NO PATIENT INJURIES AS A RESULT OF THIS MALFUNCTION AND THE MANUFACTURER STATES THEY WILL ADDRESS THE ISSUE IN THE 2ND QUARTER OF 2013.======================MANUFACTURER RESPONSE FOR INFUSION PUMP, PLUM A (PER SITE REPORTER).======================MANUFACTURER WILL ADDRESS THIS ISSUE IN 2ND QUARTER 2013.======================MANUFACTURER RESPONSE FOR INFUSION PUMP, PLUM A+3 (PER SITE REPORTER).======================MANUFACTURER WILL ADDRESS THIS ISSUE IN 2ND QUARTER 2013.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
    154441 PLUM PUMP, INFUSION FRN HOSPIRA PLUM A *
    154442 PLUM PUMP, INFUSION FRN HOSPIRA A+3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *