BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 THERAPY PUMP

    MDR report key: 1062352 · Received June 18, 2008

    Report

    Report Number
    2921482-2008-00193
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 23, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K023062
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. THE CUSTOMER CONTACT STATED THE DEVICE PASSED SUBSEQUENT TESTING AND WAS RETURNED TO CLINICAL SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING, THE DEVICE DELIVERED LESS THAN EXPECTED. IN 2008, DURING SUBSEQUENT TESTING, THE DEVICE PASSED TESTING. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA