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
    32449
  • Event Risk Class
    Class 2
  • Event Number
    Z-0033-06
  • Event Initiated Date
    2005-06-16
  • Event Date Posted
    2005-10-08
  • 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=40109
  • 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
    Software, Transmission And Storage, Patient Data - Product Code NSX
  • Reason
    If a pharmacy end user alters the administration unit of measure (auom) of an ordered drug, the auom will display incorrectly on the medication administration record for the patient, possibly leading to medication errors.
  • Action
    Urgent Device Correction recall letters dated 6/16/05 were sent to the direct accounts on the same date via first class mail. The letter describes the issue with the Administration Unit of Measure (AUOM), and informed the accounts that changing the AUOM of an ordered drug presents a patient safety issue resulting in a potential for a medication error. The accounts were requested to eliminate or minimize any further AUOM changes until a software upgrade is available. If an AUOM change is required the pharmacy end user must contact the Baxter Patient Care Helpdesk at 1-877-835-2727 prior to any changes being made. A Technical Bulletin was provided with the letter to guide the pharmacy end user through the process of an AUOM change with the aide of a Client Support Specialist.

Device

Device Recall Baxter's Patient Care System
  • Model / Serial
    Software version 4.1-77, 4.0-66 and 3.4-18.24
  • 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, composed of Pharmacy Management - Inpatient - product code 2M5013, Point of Care - product code 2M5014 and Management Reports - product code 2M5015; 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