BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR BOLUSCORD (EACH)

    MDR report key: 1881954 · Received October 12, 2010

    Report

    Report Number
    2921482-2010-00771
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    June 1, 2010
    Report Date
    September 29, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE DID NOT DELIVER. THE BOLUS CORD WAS CONNECTED TO AN UNSPECIFIED GEMSTAR PUMP AND WAS RETURNED TO THE ASSET MANAGER WITH AN UNSIGNED NOTE THAT INDICATED THAT THE DEVICE DID NOT WORK. NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING USER FACILITY TESTING, IT WAS NOTED THAT THE DEVICE DID NOT DELIVER A DOSE AFTER THE BUTTON ON THE BOLUS CORD WAS PRESSED. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES 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 BOLUSCORD (EACH) 80FRN FRN HOSPIRA, INC. NA UNKG1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GEMSTAR PUMP: LIST #UNK, SN UNK