BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+

    MDR report key: 3062650 · Received April 11, 2013

    Report

    Report Number
    3062650
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 1, 2012
    Report Date
    April 11, 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 MULTIPLE PROBLEMS WITH HOSPIRA PLUM A+ AND PLUM A+3 INFUSION PUMPS AT OUR HOSPITAL (>200). THE INFUSER FLUID SHIELD DIAPHRAGM MAY BE OUT OF SPECS. THE ERROR CODES THAT MAY APPEAR ARE N250 AND N100. THE ROOT CAUSE APPEARS TO BE UNDERSIZED (OUT OF SPECS) FLUID SHIELD DIAPHRAGMS. THIS MAY CAUSE A DELAY IN THERAPY. HOSPIRA STATES THEY WILL ADDRESS THIS ISSUE IN THE 2ND QUARTER OF 2013. NO PATIENTS HAVE BEEN HARMED.======================MANUFACTURER RESPONSE FOR INFUSION PUMP, PLUM A+ (PER SITE REPORTER).======================MANUFACTURER WILL ADDRESS THIS ISSUE IN THE 2ND QUARTER OF 2013.======================MANUFACTURER RESPONSE FOR INFUSION PUMP, PLUM A+3 (PER SITE REPORTER).======================MANUFACTURER WILL ADDRESS THIS ISSUE IN THE 2ND QUARTER OF 2013.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?INFUSION THERAPY.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
    156607 PLUM A+ PUMP, INFUSION FRN HOSPIRA INC * *
    156608 PLUM A+3 PUMP, INFUSION FRN HOSPIRA INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *