BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE PCA

    MDR report key: 3070303 · Received April 12, 2013

    Report

    Report Number
    3070303
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 1, 2012
    Report Date
    April 12, 2013
    Manufacturer
    HOSPIRA INC
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    THE DOOR CAN BE FLEXED TO THE POINT WHICH ALLOWS UNAUTHORIZED PERSONNEL TO USE OBJECTS TO PRESS THE VIAL TO RECEIVE A BOLUS OF MEDS. NO PATIENT INJURIES HAVE BEEN REPORTED AND THE MANUFACTURER STATES THE PROCESS TO CORRECT ALL DEVICES IMPACTED BY THIS ISSUE IN 4TH QUARTER 2013.======================MANUFACTURER RESPONSE FOR PCA PUMP, LIFECARE PCA (PER SITE REPORTER).======================HOSPIRA WILL BEGIN THE PROCESS TO CORRECT ALL DEVICES IMPACTED BY THIS ISSUE IN THE 4TH QUARTER OF 2013.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?IV MEDICATION ADMINISTRATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158091 LIFECARE PCA PUMP, INFUSION, PCA MEA HOSPIRA INC 20709 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *