BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMSTAR 7 THERAPY I

    MDR report key: 2113451 · Received May 31, 2011

    Report

    Report Number
    2921482-2011-00071
    Event Type
    Injury
    Date Received
    May 31, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 2, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER 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 WITHOUT SOUNDING AN AUDIBLE ALARM TONE. ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF FLOLAN, AT A RATE OF 3.7ML/HR, AND DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THE HOMECARE PT CHANGED THE PUMP DISPOSABLE BATTERIES ON (B)(6) 2011. ON (B)(6) 2011, AT AN UNSPECIFIED TIME, THE PT NOTIFIED THE HOMECARE NURSE OF AN UNSPECIFIED CHANGE IN CONDITION. AT THAT TIME, THE PT NOTED WHILE CHANGING THE MEDICATION CONTAINER AND TUBING SET THAT THE DISPOSABLE BATTERIES HAD FALLEN OUT OF THE PUMP AND THE PUMP HAD POWERED OFF. IT WAS REPORTED THE PUMP DID NOT SOUND AN AUDIBLE TONE. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THE PT'S CONDITION IMPROVED; HOWEVER, IT WAS REPORTED THE PT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PT WAS DISCHARGED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR 7 THERAPY I 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization FLOLAN: MANUFACTURER UNK