BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 1854612 · Received September 9, 2010

    Report

    Report Number
    2921482-2010-00690
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    June 28, 2010
    Report Date
    August 12, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. THE DEVICE PASSED TESTING AT THE USER FACILITY AND WAS RETURNED TO CLINICAL SERVICE. 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 REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT RECEIVED MORE MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED FOR PAIN MANAGEMENT, IN THE CONTINUOUS+BOLUS MODE, TO DELIVER FENTANYL 10MCG/ML, AT 25MCG/HR, A 12MCG BOLUS, A 10 MIN PATIENT LOCKOUT, A 6 BOLUS/HR LIMIT, A 250ML CONTAINER SIZE AND THE DELIVERY WAS STARTED. ON 06/28/2010 AT AN UNSPECIFIED TIME, THE NURSE NOTED THE DISPLAY INDICATED THAT A VOLUME OF 35ML REMAINED TO BE INFUSED; HOWEVER, 1ML REMAINED IN THE CONTAINER. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE CUSTOMER CONTACT STATED THERE WAS NO CHANGE IN THE PT STATUS. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR GEMSTAR TUBING SET, LIST #UNK, LOT #UNK