| Subject: | FDA Provides Updated Public Health Notification for Gambro Prisma Continuous Renal Replacement System |
| Category: | Food and Drug Administration (FDA)
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| Published: | Wed, 15 Mar 2006 - 10:00 am |
| The FDA has become aware of additional serious injuries and deaths associated with the use of the Gambro Prisma Continuous Renal Replacement Therapy (CRRT) device since the release of a preliminary Public Health Notification in August 2005.
The FDA is emphasizing that special caution must be used when operating the Prisma System to prevent excessive fluid removal from patients.
Caregivers must adhere strictly to the labeled operating instructions, including the Manufacturer's Instructions... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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