BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR DOCK STA

    MDR report key: 2102835 · Received April 12, 2011

    Report

    Report Number
    2921482-2011-00061
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 18, 2011
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO 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. IT WAS REPORTED THAT DURING TESTING OF THE DEVICE PRIOR TO PT USE, THE PUMP DID NOT DELIVER A BOLUS DOSE AFTER THE BOLUS BUTTON ON THE BOLUS CORD WAS PRESSED. THE DEVICE WAS REPLACED AND THERAPY WAS INITIATED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF CONTACT PINS WERE MISSING FROM THE BOLUS CORD CONNECTION PORT. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTR DOCK STA 80FRN FRN HOSPIRA, INC. NA 84824G1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA GEMSTAR BOLUS CORD: LIST #13027, LOT #UNK| GEMSTAR PUMP: LN UNK, SN UNK