BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR PM PMP ENGLSH

    MDR report key: 1854015 · Received September 2, 2010

    Report

    Report Number
    2921482-2010-00669
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 6, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    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 THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. DURING TESTING, THE DEVICE DELIVERED A MEASURED VOLUME OF 20.24ML FROM AN EXPECTED DELIVERY OF 20ML. DELIVERY ACCURACY FOR THIS DEVICE REQUIRES DELIVERY OF 20ML +/-1ML (+/-5%). THE DEVICE HISTORY WAS DOWNLOADED AT THE SVC CTR. A REVIEW OF THE DEVICE HISTORY FOUND THERE IS NO DEVICE PROGRAMMING OR DEVICE ACTIVITY FOR THE REPORTED EVENT DATE OF (B)(6) 2010; THEREFORE, THE HISTORY CANNOT BE UTILIZED TO EVALUATE THE REPORTED EVENT. 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 DELIVERED LESS MEDICATION THAN EXPECTED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT WITH AN UNSIGNED NOTE THAT STATED: "THE PUMP DELIVERS MUCH LESS VOLUME." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. 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 INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTR PM PMP ENGLSH 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK