Events

Recall of Device Recall 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
    34244
  • Event Risk Class
    Class 2
  • Event Number
    Z-0552-06
  • Event Initiated Date
    2005-12-21
  • 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=43326
  • 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
    Delivery of unrequested pca doses of medication due to damaged pca cords, partial sticking of pca button, and fluid ingress into the pump or pca button.
  • Action
    Baxter sent Urgent Device Correction letters dated 12/21/05 to the direct accounts on the same date via first class mail. The letters informed the accounts of the potential for unrequested PCA doses due to an electrical short in the PCA circuit simulating repeated pressing of the PCA button. The unrequested bolus doses will not exceed the programmed prescription limits. The letter listed three conditions identified that can produce an electrical short in the PCA circuit and simulate repeated pressing of the PCA button: * Damaged PCA cord or button, * Partial sticking of the PCA button, and * Fluid ingress into the pump or PCA button. Information was provided to reduce the potential for these conditions from occurring during use of the pumps. Customers were asked to ensure that prior to or after each use the PCA cord is intact and has no cuts or missing insulation, and that the pump connector and the button are securely attached to the cord. They were also asked to immediately take the pump and PCA cord out of service for repair if the pump displays 'Release the PCA Button' and the PCA button is not being intentionally pressed, as there may be a mechanical or electronic fault in the PCA button. They were also asked two avoid getting liquids inside the pump as permanent damage may result. Baxter recommended that the institutions implement a regular preventative maintenance program and periodic replacement of the PCA cords based on their own specific usage patterns. 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 and the PCA II Infusion Pump, with the warnings to ensure that prior to or after each use that the PCA cord is intact and has no cuts or missing insulation, and that the pump connector and the button are securely attached to the cord; to avoid getting liquids inside the pump; and

Device

Device Recall 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, China, Hong Kong, Korea, Kuwait, Malaysia, Taiwan and Saudi Arabia
  • 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