BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR DOCK STA

    MDR report key: 1900298 · Received October 25, 2010

    Report

    Report Number
    2921482-2010-00827
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 28, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND A DOSE WAS NOT DELIVERED WHEN THE BOLUS BUTTON ON THE BOLUS CORD WAS PRESSED. THIS WAS DUE TO A MISSING BOLUS CORD CONTACT PIN ON THE DOCKING STATION. THE PROBABLE CAUSE FOR THE MISSING DOCKING STATION FEMALE CONTACT PIN IS MISHANDLING OF THE DEVICE WHEN REMOVING THE BOLUS CORD THE CONNECTION PORT. ACTIONS SUCH AS TWISTING OR ATTEMPT TO REMOVE AT AN EXTREME ANGLE MAY CAUSE THE DOCKING STATION FEMALE CONTACT PINS TO REMAIN IN CONTACT WITH THE MALE PINS ON THE BOLUS CORD. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPITAL PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE DID NOT DELIVER. THE DEVICE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF THE "UNIT FAILS TO RECOGNIZE BOLUS SWITCH." MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTR DOCK STA 80FRN MEA HOSPIRA, INC. NA 48961G1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK