Events

Recall of Device Recall RenalSoft

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Renal Div.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    45856
  • Event Risk Class
    Class 2
  • Event Number
    Z-0527-2008
  • Event Initiated Date
    2007-11-14
  • Event Date Posted
    2008-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66269
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Semi-Automatic Peritoneal Dialysate Delivery System - Product Code KPF
  • Reason
    Pre-treatment/post-treatment report errors: 1) the heparin bolus value is displayed on pre and post treatment reports for patients with "no heparin" orders (renalsoft v2.0, renal software suite v.3.0 and v.3.1), and 2) withheld medications are incorrectly displayed as administered on the pre-treatment report (renalsoft v.2.0 only).
  • Action
    Baxter Healthcare Corporation sent an Urgent Device Correction letter, dated 11/14/07, to all of the affected customers, informing them of the Heparin Bolus and the Withheld Medication issues and provided them with interim mitigation instructions that they should implement while waiting for a software correction. A Baxter representative will contact the customer to schedule the software update when the upgraded software is released. Customers were requested to complete and return the enclosed Customer Reply Form, indicating that they have disseminated the information to their staff, and indicating if they still have RenalSoft software and require an upgrade. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, option 4. A follow-up letter dated 3/6/08 was sent to the consignees on the same date, informing them that the upgraded RenalSoft Software v.2.0.1 was now available for installation. The consignees were requested to complete and fax back the customer reply form indicating that they received the letter, and were informed that they would be contacted by a Baxter representative to schedule an installation of the software upgrade at no charge.

Device

Device Recall RenalSoft
  • Model / Serial
    Version 2.0 - HD Module, Serial Numbers 17023766 to 17026503
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including Puerto Rico, and countries of Australia, Austria, Canada, Chile, Denmark, Finland, Greece, Ireland, Italy, Mexico, The Netherlands, New Zealand, Norway, Panama, Portugal, Spain, Sweden and the United Kingdom
  • Product Description
    Baxter RenalSoft v.2.0 Patient Management Software Suite - HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085
  • Manufacturer
    Baxter Healthcare Renal Div

Manufacturer

Baxter Healthcare Renal Div
  • Manufacturer Address
    Baxter Healthcare Renal Div, 1620 Waukegan Rd Bldg R, Mc Gaw Park IL 60085-6730
  • Source
    USFDA