FDA Logo links to FDA home page
Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Biologics Evaluation and Research
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | CBER A-Z Index | CBER Search | Contact CBER | CBER Home Page

horizontal rule
CBER links to product areas Blood Vaccines Cellular/Gene Therapy Tissue Devices
CBER links Products Industry Healthcare Reading Room Meetings What's New
horizontal rule

Medical Device Notification
HNA Classic 306 Patient Manager Blood Bank Software

horizontal rule

DATE NOTIFICATION INITIATED:

    February 25, 2005

PRODUCT / LOT NUMBER

    HNA Classic 306 Patient Manager - Revision 159 and higher

MANUFACTURER:

    Cerner Corp
    Kansas City, MO

REASON:

    A problem has been identified with the HNA Classic Patient Manager (Rev 159 and higher). This problem occurs when a patient name is changed in Patient Registration (PAR) or Patient Encounter Maintenance (PMT). The patient's antibodies may be removed from the Blood Bank record or the Blood Bank record may be removed entirely from the Cerner system. The software problem will be corrected with the installation of a software patch.

horizontal rule

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

 

 
horizontal rule