BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSTAR AC PWR VC

    MDR report key: 3912739 · Received May 14, 2014

    Report

    Report Number
    3008785455-2014-00005
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 14, 2014
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNK. THE CUSTOMER CONTACT IDENTIFIED TWO POSSIBLE LOT NUMBERS (PLOTS). THE POSSIBLE LOT NUMBERS ARE 15196G1 AND 12148G1. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A POWER LOSS WHILE OPERATING ON AC POWER. IT WAS REPORTED THAT GEMSTAR AC POWER ADAPTER WAS CONNECTED TO A GEMSTAR PUMP AND WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF MORPHINE. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT AC ADAPTER STOPPED WORKING. THE CUSTOMER CONTACT REPORTED THAT THERE WAS A BATTERY CONNECTED TO THE PUMP AND THE AC ADAPTER WAS REPLACED. NO SPECIFIC DETAILS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THERE A DELAY OF THERAPY; HOWEVER, THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287952 GSTAR AC PWR VC 80FRN FRN HOSPIRA, INC. NA PLOTSG1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED GEMSTAR PUMP LIST #UNK, SN #UNK.