BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS EXTSET YS NON-CONVERTIBLE PIN NONDEHP

    MDR report key: 3842907 · Received March 13, 2014

    Report

    Report Number
    9615050-2014-01926
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 19, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K103224
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECIEVED. INVESTIGATION IS NOT COMPLETE. 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 NO FLOW. THE CUSTOMER CONTACT REPORTED THAT THE TUBING SET WAS PRIMED WITHOUT DIFFICULTY AND WAS LOADED INTO AN UNSPECIFIED GEMSTAR PUMP AND WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF FENTANYL 100ML, AT A RATE OF 6ML/HR. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PT REPORTED TO THE NURSE THAT THE PAINLESS TREATMENT WAS NOT WORKING. IT WAS REPORTED THAT THE NURSE CHECKED AND FOUND THAT THE SOLUTION IN THE TUBING SET DID NOT DRIP DOWN AND THAT THE SOLUTION FLOWED BACK. REPORTEDLY, THE PUMP ALARMED FOR AN EMPTY CONTAINER. NO SPECIFIC DETAILS WERE PROVIDED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. IT WAS REPORTED THAT THE PT EXPERIENCED AN UNSPECIFIED INCREASE IN PAIN; HOWEVER, THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING TESTING OF THE DEVICE AT THE HOSPIRA SERVICE CENTER, NO FLOW AND BACK FLOW OF SOLUTION WERE NOTED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150386 GS EXTSET YS NON-CONVERTIBLE PIN NONDEHP 80FPA FPA HOSPIRA COSTA RICA LTD. NA 320385H

    Patients

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