BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 3144451 · Received May 29, 2013

    Report

    Report Number
    9615050-2013-01410
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 2, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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 INDICATES ON (B)(6) 2013 AT 1312, THE DEVICE POWERED ON USING BATTERIES PROGRAMMED FOR CONTINUOUS ONLY IN ML, AT A RATE OF 3 ML/HR, A VTBI (VOLUME TO BE INFUSED) OF 66 ML, AND THE DELIVERY WAS STARTED. ON (B)(6) 2013 BETWEEN 0624 AND 0804, 17 LOW BATTERY ALARMS OCCURRED. BETWEEN 0806 AND 0823, THE DELIVERY WAS STOPPED, THE DELIVERY WAS STARTED, A LOW BATTERY ALARM OCCURRED, THE DELIVERY WAS STOPPED, AND THE DELIVERY WAS STARTED. BETWEEN 0823 AND 1115, 27 LOW BATTERY ALARMS OCCURRED AND AN END OF INFUSION ALARM OCCURRED. BETWEEN 1121 AND 1131, 2 LOW BATTERY ALARMS OCCURRED, THE DELIVERY WAS STOPPED, THE DEVICE WAS POWERED OFF. A REVIEW OF THE DEVICE 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 PATIENT RECEIVED LESS MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF 5FU, AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE HOMECARE PATIENT RETURNED TO THE USER FACILITY AS PLANNED TO HAVE THE DELIVERY DISCONTINUED AND THE DEVICE DISCONNECTED. AT THAT TIME, THE CUSTOMER CONTACT NOTED THAT ABOUT 15% OF THE VOLUME OF SOLUTION REMAINED IN THE CONTAINER. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERE WERE NO REPORTS OF ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THE CUSTOMER CONTACT INDICATED THE PATIENT MAY HAVE PRESSED AN UNSPECIFIED INCORRECT BUTTON DURING THE DELIVERY. NO SPECIFIC DETAILS WERE PROVIDED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING IF THERAPY WAS COMPLETED USING A REPLACEMENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234065 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1