BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPIRA GEMSTAR AMBULATORY INFUSION PUMP

    MDR report key: 3231164 · Received July 10, 2013

    Report

    Report Number
    3231164
    Event Type
    Malfunction
    Date Received
    July 10, 2013
    Report Date
    July 9, 2013
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT IS ON HOME ANTIBIOTIC IV INFUSION VIA A PICC LINE. HE CALLED THE INFUSION CENTER TO LET THEM KNOW THAT HIS PUMP WAS BEEPING AND NOT INFUSING THE MEDICATION AS PLANNED. THE PICC LINE WAS RULED OUT AS HAVING ANY PROBLEMS. THE INFUSION CENTER CHECKED THE PUMP FOR THE PATIENT AND IT WAS SHOWING "ERROR CODE." TROUBLE-SHOOTING WAS UNABLE TO CORRECT THE PROBLEM. THE PUMP WAS TAKEN OUT OF SERVICE AND A NEW PUMP WAS GIVEN TO THE PATIENT. OUR CLINICAL ENGINEERING STAFF CHECKED THE PUMP AND ALSO GOT THE "ERROR CODE" UPON POWERING UP THE MACHINE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HOME INFUSION OF IV ANTIBOTICS VIA A PICC LINE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317944 HOSPIRA GEMSTAR AMBULATORY INFUSION PUMP PUMP, INFUSION FRN HOSPIRA, INC. 13087-04-26 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR NO OTHER THERAPIES