Events

Recall of Baxter AP II Pain Management 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
    33916
  • Event Risk Class
    Class 2
  • Event Number
    Z-0550-06
  • Event Initiated Date
    2005-10-27
  • Event Date Posted
    2006-04-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42740
  • 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
    Pump, Infusion, Pca - Product Code MEA
  • Reason
    When infusing at flow rates below 0.5 ml/hr, the upstream occlusion alarm of the pumps may not detect the occlusion.
  • Action
    Baxter sent Urgent Device Correction letters dated 10/27/05 to the direct accounts on the same date via first class mail. The letters informed the accounts of the potential for air to migrate through the silicone-pumping segment of the sets, which may result in air reaching the patient. Baxter recommended that the users of the I-Pump to enable the upstream occlusion sensor of the pump or to use sets containing air-elimination filters if the occlusion sensor is disabled or otherwise not activated. Baxter also recommended that for delivery routes other than epidural and subcutaneous at flow rates below 0.5 mL/hr, infusions should always be performed using a set containing an air eliminating filter (product codes 2L3513, 2L3520, 2L3523, 2L3525, 2L3526 and 2L3527). For users of the APII Pump Baxter recommended that all infusions on the APII, for delivery routes other than epidural and subcutaneous, should be performed using a set containing and air-eliminating filter. Baxter sets not containing an air-eliminating filter (product codes 2L3510 and 2L3511) should not be used with the APII device, and should not be used with the I-Pump when infusing at rates less than 0.5 mL/hr. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter sent a follow-up recall letter to the accounts on 6/21/06, providing them with an Operator's Manual Addendum for the AP II Infusion Pump, with the warning to use only Baxter sets with air-eliminating filters with the AP II pump to avoid undetected air-in-line at low flow rates. The accounts were requested to complete and fax back to Baxter the enclosed reply form, indicating the number of additional copies of the addendum needed.

Device

Baxter AP II Pain Management System
  • Model / Serial
    All serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including Puerto Rico, and internationally to Canada, Chile and China
  • Product Description
    AP II Pain Management System infusion pump, product codes 2L3105, 2L3105K, 2L3105R, 2L3105T and 2L3105W; Baxter Healthcare Corporation, Deerfield, IL 60015
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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