BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PM PMP

    MDR report key: 2043198 · Received February 24, 2011

    Report

    Report Number
    2921482-2011-00033
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 27, 2011
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. 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 A DOSE WHEN THE BUTTON ON THE BOLUS CORD WAS PRESSED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED "BOLUS CORD DOESN'T WORK". NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT DELIVER A DOSE WHEN THE BUTTON ON THE BOLUS CORD WAS PRESSED. THERE WERE NO REPORTS OF ANY ADVERSE PT 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 PM PMP 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK