BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMSTAR PM THERAPY S

    MDR report key: 2120246 · Received June 7, 2011

    Report

    Report Number
    2921482-2011-00077
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 10, 2011
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE DEVICE HISTORY ON (B)(4) 2011 AT 0956, INDICATES THE DEVICE WAS PROGRAMMED FOR PAIN MANAGEMENT IN THE CONTINUOUS MODE, WITH A 7ML/HR RATE, AND A 90ML CONTAINER SIZE. AT 1046, THE DELIVERY WAS STARTED. AT 2226, AN ALMOST EMPTY ALARM OCCURRED. BETWEEN 2242 AND 2246, THE DELIVERY WAS STOPPED, A NEW CONTAINER IS INDICATED AND THE DELIVERY STARTED. BETWEEN 2345 AND 2347, DELIVERY WAS STOPPED, A 9ML/HR RATE AND A 50 ML CONTAINER SIZE WERE PROGRAMMED AND DELIVERY STARTED. A DATE OF (B)(4) 2011 OCCURRED. BETWEEN 0405 AND 0411, AN ALMOST EMPTY ALARM OCCURRED, THE DELIVERY WAS STOPPED, A NEW CONTAINER IS INDICATED, AND DELIVERY STARTED. BETWEEN 0617 AND 0623, THE DELIVERY WAS STOPPED, A CHECK CASSETTE ALARM OCCURRED, CASSETTE REINSERTED, THE SHIFT TOTALS WERE CLEARED, AND DELIVERY STARTED. BETWEEN 0921 AND 1003, AN ALMOST EMPTY ALARM OCCURRED AND WAS SILENCED, AN EMPTY CONTAINER ALARM OCCURRED, DELIVERY WAS STOPPED, PROGRAM CLEARED, A 9ML/HR RATE AND 18ML CONTAINER SIZE WERE PROGRAMMED AND DELIVERY STARTED. BETWEEN 1058 AND 1100, THE INFUSION WAS STOPPED AND THE DEVICE WAS POWERED OFF. A REVIEW OF THE HISTORY INDICATED THE DEVICE DELIVERED AS PROGRAMMED. 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 THE DEVICE DID NOT DELIVER. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED FOR PAIN MANAGEMENT IN THE CONTINUOUS MODE TO DELIVER ROPIVACAINE 0.2% AND FENTANYL 2MCG/ML, AT A RATE OF 7ML/HR, A CONTAINER SIZE 100ML & THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. ON (B)(6) 2011 AT 2300, THE PHYSICIAN INCREASED THE RATE TO 9ML/HR DUE TO THE PT'S COMPLAINT OF PAIN. THE CUSTOMER CONTACT REPORTED THE PT CONTINUED TO COMPLAIN OF PAIN DURING THE NIGHT. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE REPORTED THE DEVICE ALARMED FOR "NEW CONTAINER." AT THAT TIME, IT WAS NOTED THE MEDICATION CONTAINER WAS FULL. IT WAS REPORTED THE DEVICE "APPEARED" TO BE DELIVERING; HOWEVER, THE DEVICE WAS NOT DELIVERING. THE NURSE REPORTED OPENING THE AIR VENT OF THE TUBING SET AND REINSERTING THE CASSETTE INTO THE DEVICE. ON (B)6) 2011 AT 1300, THE CUSTOMER CONTACT REPORTED THE PT'S SYSTOLIC BLOOD PRESSURE DECREASED TO 70MMHG-80MMHG FROM AN UNSPECIFIED BASELINE. THE PHYSICIAN WAS NOTIFIED. AT THAT TIME, THE PT WAS TREATED WITH A 250ML BOLUS OF NORMAL SALINE AND DELIVERY RATE OF THE ROPIVACAINE AND FENTANYL WAS DECREASED TO 7ML/HR. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THERAPY WAS RESUMED WITH A REPLACEMENT DEVICE AND WHEN THE DEVICE WAS REMOVED FROM CLINICAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR PM THERAPY S 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention FENTANYL 2MCG/ML, MANUFACTURER UNK| ROPIVACAINE 0.2%, MANUFACTURER UNK