BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 SP NEW

    MDR report key: 3010841 · Received March 14, 2013

    Report

    Report Number
    9615050-2013-00372
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 13, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 WHILE OPERATING ON BATTERY POWER, THE PUMP POWERED OFF WITHOUT SOUNDING AN AUDIBLE ALARM. ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVER 2000ML OF TOTAL PARENTAL NUTRITION (TPN) AT A RATE OF 20ML/HR AND THE DELIVERY WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PT REPORTED THE DEVICE POWERED OFF WITHOUT SOUNDING AN AUDIBLE ALARM. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THE THERAPY WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTS OF ADVERSE PT EFFECTS AND NO REPORTED DELAYS IN THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING TESTING AT THE USER FACILITY, THE PUMP POWERED OFF WITHOUT SOUNDING AN AUDIBLE ALARM. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108298 GEMSTAR 7 SP NEW 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR