Safety Alert for HOMECHOICE FOR DIALISE PERITONEAL BAXTER - Reg. 10068390123

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.

The possibility of excessive volume infusion can occur when the machine's initial "O. inrnic" drain alarm is set to "N", and a change in the expected drain volume is performed during the warning: "See drain inic XXXXML" . Essentially, if a very low initial drain alarm volume is programmed into the HomeChoice machine, incomplete initial drainage may occur. If this occurs followed by a complete infusion, the patient may present an excess of volume in his peritoneal cavity and possible adverse clinical reactions due to this excess. The first step to prevent this from occurring is to ensure that the initial drain alarm volume "Init Drain": is properly adjusted when initiating DPA therapy in HomeChoice and discourages subsequent changes in the program. The initial drain alarm volume "Initial Drain AI:" must be adjusted in the "Set Parameters" menu. 70% of the last volume infused in the HomeChoice or manual CAPD exchange is generally considered an initial percentage to determine the optimal setting of the initial drain alarm volume. If the initial drain alarm volume is set to a low volume in software versions 8.5 and later, HomeChoice will automatically alert the user to "View drain inc. XXXXML" at the start of each therapy. DPA. This will allow the user to temporarily increase the initial drainage alarm volume for this therapy, if necessary. This function was designed to meet the needs of those patients who started intermittent DPA therapy with fluid in their peritoneal cavity. If the patient initiates DPA therapy with fluid in their peritoneum, the initial drainage alarm volume should be increased to ensure incomplete initial drainage is not performed. If you have determined that a low initial drain alarm volume is most appropriate for your patient and the alarm volume is currently at "N", you must necessarily change the initial drain alarm volume that is "N" to "OML "in the" Set parameters "menu. If in future the patient's prescription requires that the initial drain alarm volume be temporarily increased using the "See drain inc .: XXXXML" function, this will ensure that the "Drain Low" function is activated. is fully active to prevent incomplete initial drainage. If you have any questions about this, please contact your Baxter Hospitalar Ltda representative, call the service center at 0800 12 55 22, option 3 or send an e-mail to Product Specialist, Edméia Mariani, edmeia_mariani @ baxter.com. The Technovigilance Unit / ANVISA will be following the corrective actions carried out on the machines with software versions 8.5 and later.