BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR DOCKING STATION

    MDR report key: 1931792 · Received November 22, 2010

    Report

    Report Number
    2921482-2010-00925
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 1, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. REPORT 2 OF 2 OF THIS EVENT WAS SUBMITTED UNDER MFR REPORT #2921482-2010-00926. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    REPORT 1 OF 2. THE CUSTOMER CONTACT REPORTED AN ELECTRICAL SHOCK. THE DOCKING STATION WAS CONNECTED TO A GEMSTAR PUMP. THE PUMP WAS BEING USED TO DELIVER UNSPECIFIED CONCENTRATIONS OF FENTANYL AND MARCAINE IN 100ML OF NORMAL SALINE AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED THAT THE SOLUTION CONTAINER WAS LEAKING FLUID ONTO THE PUMP AND DOCKING STATION. IT WAS REPORTED THAT WHEN THE NURSE REMOVED THE TUBING SET FROM THE PUMP THE NURSE RECEIVED AN ELECTRIC SHOCK TO THE HAND. THE NURSE REPORTED A "BURNING SENSATION" WHICH COMPLETELY DISAPPEARED AFTER SEVERAL HOURS. THE DOCKING STATION WAS REMOVED FROM CLINICAL SERVICE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE NURSE. NO MEDICAL INTERVENTIONS WERE REPORTED. THERE WERE NO REPORTED ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPY WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, FLUID WAS FOUND INSIDE THE DOCKING STATION, THE DOCKING STATION WAS NOT FUNCTIONAL, AND A BURNING SMELL WAS REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR DOCKING STATION 80FRN FRN HOSPIRA, INC. NA 41802G1

    Patients

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