Events

Recall of Device Recall RenalSoft Observational Study v.2.0

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
    34943
  • Event Risk Class
    Class 2
  • Event Number
    Z-0831-06
  • Event Initiated Date
    2006-03-29
  • Event Date Posted
    2006-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44979
  • 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
    System, Dialysate Delivery, Semi-Automatic, Peritoneal - Product Code KPF
  • Reason
    Software error: there are software discrepancies that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.
  • Action
    Baxter sent Urgent Device Correction letters dated 3/29/06 to those customers who had their RenalSoft and Renal Software Suite software configured with the affected modules. The letters indicated in a table which software anomalies were associated with the affected software modules in each software version. A description of each anomaly was provided, along with interim actions to take to mitigate the anomaly until the new software version RenalSoft V.2.0.x can be issued. Individual customer training will be performed at each facility for those issues identified in the letter specific to their software version. At that time the mitigation provided in the letter will be reviewed with the customer.

Device

Device Recall RenalSoft Observational Study v.2.0
  • Model / Serial
    version 2.0 - HD Modules, PD Modules and Medical Record Modules only
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide (Alabama, Arizona, California, Colorado, Connecticut, Illinois, Iowa, Kansas, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New York, Pennsylvania, South Dakota,Texas and Wisconsin); and internationally to Australia, Austria, Canada, Denmark, Finland, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Spain, Sweden and the United Kingdom.
  • Product Description
    Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module and Medical Record 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