BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 1854625 · Received September 9, 2010

    Report

    Report Number
    2921482-2010-00687
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    June 11, 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 LESS MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED FOR PAIN MANAGEMENT, IN THE BOLUS ONLY MODE, TO DELIVER MORPHINE 1MG/ML, A 2.0MG BOLUS DOSE, 10 MIN PT LOCKOUT, A 6 BOLUS/HR LIMIT, AND A 100ML CONTAINER SIZE. ON (B)(6) 2010 AT AN UNSPECIFIED TIME, THE THERAPY WAS DISCONTINUED. AT THAT TIME, THE NURSE COMPARED THE PUMP DISPLAYED VOLUME REMAINING TO BE INFUSED AND THE MEASURED VOLUME OF MEDICATION THAT WAS DISCARDED. THE REPORTED DIFFERENCE WAS 20.1ML WHICH WAS REPORTED AS MORE MEDICATION REMAINING THEN EXPECTED; HOWEVER, THE EXPECTED REMAINING VOLUME WAS NOT SPECIFIED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE CUSTOMER CONTACT STATED THERE WAS NO CHANGE IN THE PT STATUS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THIS PT. 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 50 YR GEMSTAR TUBING SET, LIST #UNK, LOT #UNK