BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM

    MDR report key: 3251585 · Received April 11, 2013

    Report

    Report Number
    3251585
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 1, 2012
    Report Date
    April 11, 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 A LOT OF PROBLEMS WITH PLUM A+ AND PLUM A+3 INFUSION PUMPS AT OUR HOSPITAL (GREATER THAN 10 EVENTS). THE INFUSER FLUID DIAPHRAGM MAY BE OUT OF SPECIFICATIONS (SPECS). ERROR CODES N250 AND N100 MAY BE OBSERVED. THE ROOT CAUSE APPEARS TO BE UNDERSIZED (OUT OF SPECS) FLUID SHIELD DIAPHRAGMS. THIS MAY CAUSE A DELAY IN THERAPY. THERE HAVE NOT BEEN ANY PATIENT INJURIES REPORTED. THE MANUFACTURER STATES THEY WILL ADDRESS THIS ISSUE IN THE 2ND QUARTER OF 2013.======================MANUFACTURER RESPONSE FOR INFUSION PUMP, PLUM A+ (PER SITE REPORTER).======================HOSPIRA WILL ADDRESS THIS ISSUE IN THE 2ND QUARTER.======================MANUFACTURER RESPONSE FOR INFUSION PUMP, PLUM A+3 (PER SITE REPORTER).======================HOSPIRA WILL ADDRESS THIS ISSUE IN THE 2ND QUARTER.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
    157161 PLUM PUMP, INFUSION FRN HOSPIRA A+3 *
    157225 PLUM PUMP, INFUSION FRN HOSPIRA A+ *

    Patients

    Seq Age Sex Outcome Treatment
    1 *