BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PAIN MGE SNG

    MDR report key: 3161818 · Received June 3, 2013

    Report

    Report Number
    9615050-2013-01498
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 6, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. THE CUSTOMER CONTACT INDICATED THAT DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING AND WAS RETURNED TO CLINICAL SVC. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENT ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT REC'D LESS MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF FENTANYL AND THE DELIVERY WAS STARTED VIA AN EPIDURAL CATHETER. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PT REPORTED INADEQUATE PAIN RELIEF. THE CUSTOMER CONTACT INDICATED THAT THE PUMP APPEARED TO BE DELIVERING PROPERLY. NO SPECIFIC DETAILS WERE PROVIDED. THE DEVICE WAS REMOVED FROM CLINICAL SVCS. THE DELIVERY WAS RESUMED USING A REPLACEMENT DEVICE AND TUBING SET. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING AND WAS RETURNED TO CLINICAL SVC. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243594 GEMSTAR PAIN MGE SNG 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GEMSTAR PRIMARY TUBING SET: LIST # 13751, LOT #UNK