11-05-2021

Homechoice Pro Automated Pd System User Manual

Homechoice Pro Automated Pd System Manual
Homechoice Pd Machine

5C4471R HomeChoice™ Automated PD System 1 each 5C8310P HomeChoice PRO™ Automated PD System (110 volt) 1 each PP eri ton alD y s S f w APD therapies are written by the clinician and transferred to the cycler with the PRO Card Window’s based software enables increased monitoring of patient adherance, drain function and ultrafiltration. Baxter has leveraged its vast PD experience with the HomeChoice System—first introduced to the market in 1994—to bring the innovative Amia Automated PD System with Sharesource Connectivity Platform to patients. Take a look at how the Amia System with Sharesource Platform compares to the HomeChoice/HomeChoice Pro Systems. Peritoneal Dialysis Peritoneal Dialysis - combined with Remote Patient Management - offers the potential to improve renal patients' clinical outcomes and increase lifestyle flexibility. Hemodialysis Hemodialysis is the predominant therapy for end-stage kidney disease,. 5C4471R HomeChoice™ Automated PD System 1 each 5C8310P HomeChoice PRO™ Automated PD System (110 volt) 1 each PP eri ton alD y s S f w APD therapies are written by the clinician and transferred to the cycler with the PRO Card Window’s based software enables increased monitoring of patient adherance, drain function and ultrafiltration. HomeChoice is an Automated Peritoneal Dialysis (APD) system that has been designed to meet the needs of many patients, including children and adults of different weights and sizes. It is used at. Consumers and health professionals are advised that Baxter Healthcare, in consultation with the TGA, is undertaking a recall for product correction of its HomeChoice Pro automated peritoneal dialysis system. The recall for product correction will add additional precautionary warnings to the Instructions for Use of the HomeChoice PRO dialysis.

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Class 2 Device Recall HomeChoice/HomeChoice PRO

Z-0939-2015
Date Initiated by Firm	October 06, 2014
Date Posted	January 07, 2015
Recall Status¹	Terminated ³ on March 28, 2016
Recall Event ID	69468
K102936
System, peritoneal, automatic delivery - Product CodeFKX
Product	HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000 mL. The HomeChoice and HomeChoice Pro APD systems are intended to be operated by: 1) Home patients whose physicians have prescribed this system. Patients, or their caregivers, must have received adequate training to use the system. 2) Clinicians who are using the system for patients under their care and under a prescription. Clinicians must have received adequate training to use the system. Since drain and volume requirements vary among patients, both the HomeChoice and HomeChoice Pro APD systems have a choice of modes, either Standard Fill Mode (Standard Mode) or Low Fill Mode. The dialysis center selects the Fill mode for the patient before therapy begins. The HomeChoice APD system and HomeChoice Pro APD system are the same in operation, except for the Pro Card and modem features that are only available with the HomeChoice Pro APD system. The Pro Card feature stores prescription and therapy data. The data can be transferred between your cycler and your clinician. The two systems use the same disposable sets and solutions. They perform the same therapies the same way.
Code Information	Product Codes: 5C4471(R), 5C8310(R); Serial Numbers: All serial numbers
Recalling Firm/ Manufacturer	Baxter Healthcare Corp. 1 Baxter Pkwy Deerfield IL 60015-4625
For Additional Information Contact	Center for One Baxter 800-422-9837
There are additional and updated warning and cautions that are not in the Patient At-Home Guide for HomeChoice Automated PD Systems and HomeChoice PRO Automated PD Systems.
Labeling design
The firm, Baxter, sent an 'IMPORTANT PRODUCT INFORMATION' letter dated October 6, 2014 to all peritoneal dialysis provider direct accounts. Baxter also sent an 'IMPORTANT PRODUCT INFORMATION' letter dated October 9, 2014 to all peritoneal dialysis patient direct accounts The letters described the product, problem and actions to be taken. The letters included instructions for the recipients to complete the attached Customer Reply Form and to return it to Baxter via scanned e-mail to: fca@baxter.com or fax : 224-270-5457. In addition, the letter to patients instructed them to contact their healthcare provider to discuss this issue. Customers with clinical questions should contact Baxter's Renal Division Clinic Helpline at 888-736-2573, option 2 (8:00 AM - 5:00 PM CST). Adverse reaction or quality problems experienced with the use of these product can be reported by contacting Baxter Product Surveillance at 800-437-5176 (Monday - Friday, 8:00 AM - 5:30 PM CST) or e-mail to corporate_product_complaints_round_lake@baxter.com. Customers with general questions about the letter should contact The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CST).
96,458 systems
Worldwide Distribution: US (nationwide) Including states of: AK, AL, AR, AZ, CA, CO, CT, DE, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and District of Columbia; and countries of: Algeria, Argentina, Aruba, Australia, Austria, Bahamas, Bahrain, Barbados, Belarus, Belgium, Bosnia, Brazil, Bulgaria, Cayman Islands, Chile, Colombia, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Macedonia, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Poland, Portugal, Quatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
TPLC Device Report
¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. ² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. ³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database	510(K)s with Product Code = FKX and Original Applicant = BAXTER HEALTHCARE CORP.