Safety Alert for (Especially designed to be used for the continuous removal of solute and / or fluids in patients with acute renal failure or overload of fluids in intensive care)

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

ANVISA through the Technovigilance Unit will monitor all relevant actions. If you have any questions, please contact GAMBRO DO BRASIL at 11 2142.2142, and for notification of an event associated with the use of the equipment, contact ANVISA - Tecnovigilância Unit through the telephone 61-3448 1485 or tecnovigilancia@anvisa.gov .br. Update (03-23-2006): The company informed the measures adopted: 1. Sending the Global Security Alert; 2. Sending the Help Card, reinforcing the information about the specific alarm; 3. Supply of the addendum to the User's Manual, as well as labels to be affixed to the Prisma machine informing about the alarm, in addition to the addition to the training material, reinforcing this same information; 4. Re-training with the clinical staff of all establishments owned by Prisma in Brazil (completion of work scheduled for 04-30-2006); 5. Incident Reporting Procedure, distributed to all Technical Service Representatives in Brazil, with actions developed worldwide by Gambro comor resulting from discussions with the FDA; 6. Second amterial re-training session developed by Gambro according to FDA requirements (no forecast as it depends on the completion and availability of the material). According to the company, "(...) both Prism System and other products from the same factory remain fit for use as long as the instructions are followed. Users must strictly follow the operating instructions, including Instructions for Use, Operator and User Interface of the Prisma System Control Panel.This information has been given to all clinics in which Prisma is in use through the Global Security Aelrta published by Gambro in August 2005. " UPDATE 06-21-2006: According to the company, the label was attached to be attached to the equipment. Two adhesive labels were prepared, as follows: Label 1 (in orange background) with the words ATTENTION SRs USERS - DO NOT IGNORE OR SURVIVE ALARMS TO THE EQUIPMENT, WITHOUT PRIOR TO SOLVING THE PROBLEM. Please check the blue label for details. Label 2 (blue background) shows an information box titled Alarm during treatment DETECTED AN INCORRECT WEIGHT CHANGE, with three columns described as follows: Problem; Possible Cause (s); Measures to adopt