BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 2181067 · Received July 7, 2011

    Report

    Report Number
    2921482-2011-00090
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    February 1, 2011
    Report Date
    June 13, 2011
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE PUMP HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE PUMP HISTORY INDICATED THE ONLY PROGRAMMING FOR THE MONTH OF (B)(6) OCCURRED ON (B)(6) 2011 AT 1644, WHEN THE PUMP WAS PROGRAMMED FOR CONTINUOUS ONLY DELIVERY IN ML, AT A RATE OF 100ML/HR, A 9999 VTBI (VOLUME TO BE INFUSED), A 0ML/HR KVO RATE (KEEP VEIN OPEN), A 9999ML CONTAINER SIZE AND THE AIR SENSITIVITY WAS OFF. AT 1647, A START ALARM OCCURRED. AT 1650, THE DELIVERY WAS STARTED. AT 1653, A 09/11/041 (MOTOR STACK ERROR) OCCURRED. AT 1654, THE DEVICE WAS POWERED ON USING BATTERY POWER, THE DELIVERY WAS STARTED. AT 1656, A 09/001/41 (BACKWARD MOTOR MOVEMENT) OCCURRED. 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 PATIENT RECEIVED LESS MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED MEDICATION, WITH A 1000ML CONTAINER SIZE, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE HOMECARE PATIENT RETURNED TO THE CLINIC. AT THAT TIME, THE NURSE REPORTED THE DEVICE DISPLAY INDICATED 1300ML HAD BEEN DELIVERED; HOWEVER, THERE WAS 400ML REMAINING IN THE CONTAINER. THE CUSTOMER CONTACT DID NOT SPECIFY THE VOLUME EXPECTED TO BE REMAINING IN THE CONTAINER. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. 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, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK