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January 3, 2000 - 2:00pm EST - Y2K Device Status Update |
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| The
Medical Devices Agency of
the United Kingdom recently issued a Y2K Special Issue Advice Notice
regarding Gambro AK100 and AK200 hemodialysis units. According to the
Advice Notice, the device can display erroneous date and time, which may
result in the failure of the timed auto-disinfect cycle. Using a manual
disinfection cycle or resetting the date and time will allow for correct
use of the device.
The FDA's Center for Devices and Radiological Health has looked into this report and discussed this problem with the manufacturer. The manufacturer has determined that these units were not sold in the United States.
The Center is aware of several medical device incidents from around the world. To the
best of our knowledge, all incidents have been minor, have primarily involved date
display and printing problems, and have not adversely affected patient safety. We
will continue our surveillance and share any significant information with the
healthcare community from the web site. |
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