Class 1 Recall: Gambro Renal Products Prisma® Continuous Renal Replacement System

Date Recall
Initiated:

August 16, 2005

Product:

Gambro Prisma® Continuous Renal Replacement System ( Model/Catalog Numbers: 018080100, 018080101, 018080001D. All serial numbers. )

Use:

The Prisma® continuous renal replacement system is a type of hemodialysis that removes, filters and returns the blood slowly and continuously in patients with acute renal failure.

Recalling Firm:

Gambro Renal Products

Reason for Recall:

Critically ill patients receiving continuous renal replacement therapy may suffer excessive fluid loss if caregivers override the device’s “Incorrect Weight Change Detected” alarm. These alarms alert caregivers to a potential fluid imbalance in the patient. If the cause of the alarm is not addressed, an excessive amount of fluid can be removed from or administered to the patient.

Public Contact:

Gambro Renal Products
10810 W. Collins Avenue
Lakewood , CO 80215-4439
800-525-2623

FDA District:

Denver

FDA Comments:

• In August 2005, Gambro issued a Safety Alert and a Field Corrective Action related to Prisma ® that included an addendum to the operator's manual, warning label for the machine, and additional training and training materials for customers and intensive care nurses working with the device to ensure proper use.
• Gambro will be providing in-service training at all health care facilities where Prisma ® Systems are located. All trainings are expected to be completed by March 1, 2006. User facilities that have not heard from Gambro should contact the company directly.
• Caregivers must never override the “Incorrect Weight Change Detected” alarms without first identifying and removing the cause of each alarm. Please see FDA’s updated Public Health Notification for additional recommendations.

FDA is working closely with the firm to ensure that documents issued by the firm to its customers contain appropriate information. For additional information please see FDA’s updated Public Health Notification at http://www.fda.gov/cdrh/safety/022706-gambro.html. Consumers with questions about the recall may contact Gambro’s 24-hour clinical assistance hotline ( 800) 525-2623.