BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 2765768 · Received September 25, 2012

    Report

    Report Number
    9615050-2012-01125
    Event Type
    Malfunction
    Date Received
    September 25, 2012
    Date of Event
    August 17, 2012
    Report Date
    August 28, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE DEVICE HISTORY INDICATED THE DEVICE WAS PROGRAMMED ON (B)(6) 2012 AT 1218, FOR PAIN MANAGEMENT, CONTINUOUS+BOLUS DELIVERY IN MG, WITH A 10MG/ML CONCENTRATION, A 13MG/HR CONTINUOUS RATE, NO LOADING DOSE, A 15 MINUTE BOLUS LOCKOUT, A 45MG 1HR LIMIT, A 5000MG/500ML CONTAINER SIZE AND THE DELIVERY WAS STARTED. AT 1226, A 8MG PT. INITIATED BOLUS DELIVERY OCCURRED AND A 09/012/035 SERVICE ALARM OCCURRED. AT 1227, THE DEVICE WAS POWERED ON, THE DELIVERY STARTED AND AN 8MG PT. INITIATED BOLUS DELIVERY OCCURRED. BETWEEN 1239 AND 1244, THERE ARE 2 UNMET BOLUS DEMANDS, A PT INITIATED BOLUS DELIVERY BEGAN AND A 09/012/035 SERVICE ALARM OCCURRED. BETWEEN 1534 AND 1538, THE DEVICE WAS POWERED ON, THE DELIVERY WAS STARTED, A 8MG PT. INITIATED BOLUS DELIVERY IS COMPLETED, THERE WAS ONE UNMET BOLUS DEMAND, A CHECK CASSETTE ALARM AND POWER LOSS ALARM OCCURRED. A REVIEW OF THE DEVICE HISTORY INDICATED THE DEVICE DELIVERED AS PROGRAMMED; HOWEVER, THE PROGRAMMED SETTINGS DO NOT MATCH THE CUSTOMER REPORTED SETTINGS. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY OF CRITICAL THERAPY FOLLOWING AN ALARM CONDITION. ON (B)(6) 2012 AT 1530, THE DEVICE WAS PROGRAMMED FOR CONTINUOUS+BOLUS DELIVERY IN MG OF MORPHINE 10MG/ML, WITH A CONTINUOUS RATE OF 16 ML/HR, A BOLUS DOES OF 11 MG, WITH A 15 MINUTE BOLUS LOCKOUT, A 60 MG DOSE LIMIT, A 500 ML CONTAINER SIZE AND THE DELIVERY WAS STARTED. ON (B)(6) 2012 AT 1230, DURING A HOME VISIT, THE NURSE REPORTED THE DEVICE ALARMED WITH AN UNSPECIFIED ALARM. AT THAT TIME, THE NURSE POWERED THE DEVICE OFF AND ON, AND THE DELIVERY WAS RESUMED. AT 1300, THE NURSE REPORTED THE DEVICE ALARMED FOR ERROR CODE 09/012/035 (MOTOR STEP OVERLAP). AT THAT TIME, THE NURSE REPORTED THE PATIENT COMPLAINED OF AN UNSPECIFIED INCREASE IN LEVEL OF PAIN. THE PATIENT WAS GIVEN ORAL MORPHINE 20 MG/ML TWICE FROM THE PATIENT'S COMFORT CARE KIT. THE NURSE REPORTED THAT THE PATIENT RESPONDED WELL TO THE ORAL PAIN MEDICATION. THE DEVICE WAS REMOVED FROM CLINICAL USE. AFTER 1 HOUR AND 20 MINUTES, THERAPY WAS RESUMED WITH A REPLACEMENT DEVICE AND TUBING SET. AT THAT TIME, A 16 MG LOADING DOSE WAS GIVEN. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EFFECTS. NO MEDIAL INTERVENTIONS WERE REQUIRED. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR