Events

Recall of Device Recall Baxter's Patient Care System

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

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
    33250
  • Event Risk Class
    Class 2
  • Event Number
    Z-0061-06
  • Event Initiated Date
    2005-08-29
  • Event Date Posted
    2005-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41544
  • 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
    Medical Computers And Software - Product Code LNX
  • Reason
    If an administrative user modifies any of the seven pre-defined monitoring parameters when they are attached to a medication in the drug file, a point of care end user will be unable to enter monitoring parameter results on the handheld.
  • Action
    Urgent Device Correction recall letters dated 8/29/05 were sent to the direct accounts on the same date via first class mail. The letter describes the issue with the modification or creation of a Monitoring Parameter, and informed the accounts that modifying the Monitoring Parameters could result in a potential for a patient receiving an incorrect medication or an incorrect medication dosage. The accounts were advised that administrative end users should never modify the seven pre-defined Monitoring Parameters or create new Monitoring Parameters.

Device

Device Recall Baxter's Patient Care System
  • Model / Serial
    all units of software versions 4.0 (66) and 4.1 (77)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Missouri, Massachusetts, Vermont, California and Canada.
  • Product Description
    Baxter''s Patient Care System (BPCS) software, Pharmacy Management - Inpatient - product code 2M5013 and Point of Care - product code 2M5014; Baxter Healthcare Corporation, 1 Baxter Parkway, Deerfield, IL 60015, USA, made in Canada
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA