BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 2397094 · Received November 29, 2011

    Report

    Report Number
    2921482-2011-00140
    Event Type
    Malfunction
    Date Received
    November 29, 2011
    Date of Event
    November 4, 2011
    Report Date
    November 4, 2011
    Manufacturer
    HOSPITA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE PUMP HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE PUMP HISTORY FOUND THAT ON THE REPORTED EVENT DATE OF (B)(6) 2011, THE PUMP WAS NOT POWERED ON; THEREFORE, THE HISTORY CANNOT BE UTILIZED TO EVALUATE THE REPORTED EVENT. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT RECEIVED LESS MEDICATION THAN INTENDED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT BY A NURSE THAT STATED THE DEVICE, "UNDER DELIVERED." NO SPECIFIC PT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE PROVIDED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAY OF CRITICAL THERAPIES WHEN 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 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPITA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK