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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Medical Device Notification: HNA Classic 306 Patient Manager Blood Bank Software-Cerner Corp

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.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448