BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMSTAR 7 THERAPY S

    MDR report key: 2831638 · Received November 9, 2012

    Report

    Report Number
    9615050-2012-01322
    Event Type
    Injury
    Date Received
    November 9, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. THE PUMP HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE PUMP HISTORY INDICATED THE PUMP POWERED ON USING AC POWER AND PROGRAMMED ON (B)(6) 2012 BETWEEN 0736 AND 0737, FOR ML/HR ONLY DELIVERY, AT A 10ML/HR RATE, A 90ML VTBI (VOLUME TO BE INFUSED) AND THE DELIVER WAS STARTED. AT 0738 THE DELIVERY WAS STOPPED, A PRIMING VOLUME OF 3.1ML OCCURRED. AT 0739, THE DELIVERY WAS STARTED AND THE RATE WAS TITRATED TO 20ML/HR. AT 0841, THE RATE WAS TITRATED TO 15ML/HR. BETWEEN 1134 AND 1138, THE DELIVERY WAS STOPPED, A 2.1ML PRIMING VOLUME OCCURRED, A START ALARM OCCURRED AND THE DELIVERY WAS STARTED. AT 1226, A POWER LOSS ALARM OCCURRED. AT 1252, THE PUMP WAS POWERED ON, USING AC POWER. BETWEEN 1255 AND 1257, A CHECK CASSETTE ALARM AND A POWER LOSS ALARM OCCURRED, THE PUMP WAS POWERED ON AND POWERED OFF. A REVIEW OF THE PUMP HISTORY INDICATED THE PUMP ALARMED FOR POWER LOSS ON THE REPORTED EVENT DATE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT WHILE OPERATING ON BATTERY POWER, THE PUMP POWERED OFF BY ITSELF W/O SOUNDING AN AUDIBLE ALARM TONE. ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF REMIFENTANIL, AT A RATE OF 0.1 MCG/KG/MIN, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT WHILE THE PT WAS BEING TRANSPORTED FROM THE URGENT AREA OF THE HOSPITAL TO DIFFERENT AREA, THE PUMP POWERED OFF BY ITSELF W/O SOUNDING AN AUDIBLE ALARM TONE. AT THAT TIME, THE PT WAS TREATED WITH AN UNSPECIFIED BOLUS DOSE OF REMIFENTANIL. THE PT WAS KEPT UNDER INTENSIVE CARE MANAGEMENT FOR CEREBRAL PROTECTION MEASURES AND HEMODYNAMIC INSTABILITY. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR 7 THERAPY S 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1