09
Feb
2005

Baxter Healthcare Renal Division Class II

0

Company: Baxter Healthcare Renal Division
Date of Enforcement Report: 2/9/05
Class: II

PRODUCT
HomeChoice PRO Automated Peritoneal Dialysis Systems. Recall # Z-0397-05.

REASON
A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD products.

CODE
Units with software version 8.7 used with Physioneal Clear-Flex PD products.

RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Division, Mc Gaw Park, IL, by notice on December 23, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
165 units.

DISTRIBUTION
Denmark and Sweden.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  June 24-26, 2025 (Virtual, Live)

For private, in-house courses, please contact us.

Email training@softwarecpr.com for more info.

 

 

Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

  • TBD
See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
office@softwarecpr.com
Partners located in the US (CA, FL, MA, MN, TX) and Canada.