Date: February 27, 2006
Original Publication: August 23, 2005
New Information in this Notification:
- Continued problems with operating the Prisma® System and,
- All user facilities should have received in-service training from Gambro on the device by March 1, 2006.
Dear Renal Dialysis Caregiver:
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 our preliminary Public Health Notification in August 2005. The Prisma® CRRT is a type of kidney dialysis system used in hospital intensive care units and other facilities for critically ill patients.
We want to emphasize again 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 for Use, Operator’s Manual, and the User Interface on the Prisma® System control panel.
Caregivers must pay particular attention to the “Incorrect Weight Change Detected” alarms. These alarms are designed to alert the user of a potential fluid imbalance that has occurred during the course of CRRT. If treatment is continued without resolving the cause of these alarms, excessive fluid may be removed from the patient, and this can result in serious injury or death.
Device design issues may also be contributing to the problem, and this is currently under investigation by both the FDA and the firm.
- When you receive an “Incorrect Weight Change Detected” alarm (Effluent Weight, Replacement Solution Weight, or Dialysate Weight) you MUST NOT press “CONTINUE” without first identifying and removing the cause of each alarm. Possible causes are listed in the Prisma Operator’s Manual and in our previous notice online. Please note that the device will not provide the user with confirmation that the problem has been resolved.
- After the cause of the alarm has been identified and the problem corrected, continue to monitor the patient’s fluid balance levels closely during treatment to make sure the problem has indeed been resolved.
- Be aware that the amount of excessive fluid removed may increase with multiple alarms, and that this problem can occur even when the fluid removal rate is set to “0 cc/hr”.
- Be aware that the amount of fluid removed (as displayed on the Prisma® System monitor) may be inaccurate. Specifically, the displayed value for the “Amount of Fluid Removed” may be off by ±60 cc/hr from the actual value.
- If you receive additional “Incorrect Weight Change Detected” alarms and the cause cannot be identified, you should first solve the problem, and then consider discontinuing and restarting the treatment, if possible.
To eliminate the chance of additional injuries or deaths, to ensure that users are trained properly on this equipment and to emphasize the importance of user awareness, Gambro will be providing in-service training at all user facilities. These trainings are expected to be completed by March 1, 2006. The firm is also alerting all medical health facilities of the excessive fluid removal problem. The training will be held at each of the health care facilities where the Prisma® Systems are located. This training will specifically address the “Incorrect Weight Change Detected” alarms and instruct users how to resolve the alarms to prevent serious adverse health consequences resulting from excessive fluid removal. Gambro Renal Products will contact all facilities directly; facilities that have the Prisma® device that have not heard from Gambro about arranging for training should contact Gambro directly. All pertinent staff should be made aware of this pending training and instructed to participate. To prevent potential serious adverse health consequences, it is critical that all Prisma® System users receive and understand this training. The completion of such training should be documented by all involved dialysis staff. In the future, Gambro Renal Products, Inc., may make modifications to the Prisma® System in order to address this problem. We will issue updates as needed to keep you aware of the situation.
The Prisma® System is used for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. Approximately 5,000 units have been distributed to hospitals worldwide, including 1,900 systems in the United States. This device has caused or contributed to a number of serious adverse events by removing excessive amounts of fluid from patients undergoing CRRT. As of today, we are aware of 9 deaths and 11 serious injuries associated with the excessive fluid removal problem. This problem can occur when the causes of one or more “Incorrect Weight Change Detected” alarms are not adequately resolved before treatment is continued. The problem may also be exacerbated by the device software and its interface with the user.
On August 16, 2005, Gambro Renal Products, Inc., issued a press release and distributed a “Worldwide Safety Alert” to all users of the Prisma® System explaining what actions to take to reduce the potential for risks associated with the device. As a follow-up to the August 16 safety alert, Gambro also provided users with the following:
(1) warning labels to be affixed to all machines;
(2) an addendum to the Operator’s Manual, including the additional warning; and
(3) a training program to educate users on how to avoid/troubleshoot this problem.
If you have any questions about the Prisma® System, instructions are provided in the Operator’s Manual or the user interface on the Control Panel. Requests for copies of the Operator’s Manual and technical questions should be addressed to Gambro’s 24-hour clinical assistance hotline at 1-800-525-2623.
Reporting to FDA
To report your experience regarding the devices in this Notification, please use MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online.
Getting More Information
FDA Medical Device Public Health Notifications are available on the Internet. You can also be notified through email each time a new Public Health Notification is added to our web page. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39.
Daniel G. Schultz, MD
Center for Devices and Radiological Health
Food and Drug Administration
* CDRH Preliminary Public Health Notifications are intended to quickly share device-related safety information with healthcare providers when the available information and our understanding of an issue are still evolving. We will revise them as new information merits and so encourage you to check this site for updates.
If you have questions about this Notification, please contact FDA's Division of of Small Manufacturers, International and Consumer Assistance (DSMICA) by e-mail at email@example.com or by phone at 1-800-638-2041 or 301-796-7100