BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+

    MDR report key: 3070183 · Received April 12, 2013

    Report

    Report Number
    3070183
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 1, 2012
    Report Date
    April 12, 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 MULTIPLE PROBLEMS WITH PLUM A+ AND PLUM A+3 INFUSION PUMPS AT OUR FACILITY (>200). THE DOOR ROLLERS HAVE A POTENTIAL TO BREAK. IF BROKEN IT COULD LEAD TO UNRESTRICTED FLOW. IN THE EVENT THE DOOR IS BROKEN, THE REGULATOR CLOSER MAY NOT CLOSE PROPERLY. NO PATIENT INJURIES HAVE OCCURRED, AND THE MANUFACTURER STATES THE ISSUE WILL BE ADDRESSED IN THE 2ND QUARTER 2013.======================MANUFACTURER RESPONSE FOR PLUM INFUSION PUMP, PLUM A (PER SITE REPORTER).======================HOSPIRA STATED THEY WILL ADDRESS THE ISSUE IN 2ND QUARTER OF 2013.======================MANUFACTURER RESPONSE FOR PLUM INFUSION PUMP, PLUM A+3 (PER SITE REPORTER).======================HOSPIRA STATED THEY WILL ADDRESS THE ISSUE IN 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
    159698 PLUM A+ PUMP, INFUSION FRN HOSPIRA INC * *
    159699 PLUM A+3 PUMP, INFUSION FRN HOSPIRA INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *