BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO GEMSTAR SPLT SET YLLW STRIPE 110IN

    MDR report key: 2181184 · Received July 7, 2011

    Report

    Report Number
    9615050-2011-00493
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 10, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 961925H AND 962285H. 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 THAT THE PT RECEIVED LESS MEDICATION THAN INTENDED. THE TUBING SET WAS BEING USED FOR DELIVERY OF AN UNSPECIFIED CONCENTRATION OF FENTANYL AND 0.125% BUPIVICAINE IN 250ML OF NORMAL SALINE VIA EPIDURAL ROUTE AT A RATE OF 10ML/HR USING A GEMSTAR PUMP. ON (B)(6) 2011, AT 1330, THE DELIVERY WAS STARTED. AT 1521, THE PT REPORTED A PAIN LEVEL OF "9" ON A SCALE OF 1 TO 10. THE PHYSICIAN WAS NOTIFIED. AT AN UNSPECIFIED TIME, THE PT WAS TREATED WITH A 6ML BOLUS DELIVERY OF 30MCG FENTANYL AND 7.5MG BUPIVICAINE. AT 1635, THE PT REPORTED A PAIN LEVEL OF "6". AT 1641, THE PT REPORTED A PAIN LEVEL OF "3". ON (B)(6) 2011, AT AN UNSPECIFIED TIME IN THE MORNING, 245ML REMAINED IN THE SOLUTION CONTAINER. THE TUBING SET AND THE PUMP WERE REPLACED AND THE THERAPY WAS RESUMED. DURING TESTING AT THE USER FACILITY, THE DEVICE DELIVERED LESS THAN INTENDED USING A TEST GEMSTAR PUMP. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO GEMSTAR SPLT SET YLLW STRIPE 110IN 80FPA FPA HOSPIRA COSTA RICA LTD. NA PLOTS5H

    Patients

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