Events

Recall of Baxter AMIA APD 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
    70194
  • Event Risk Class
    Class 2
  • Event Number
    Z-1245-2015
  • Event Initiated Date
    2014-04-03
  • Event Date Posted
    2015-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132475
  • 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, recirculating - Product Code FIK
  • Reason
    Additional warning in the amia apd system labeling for patients vulnerable to unintended increased intraperitoneal volume (iipv), also known as overfill. the patients include neonates, infants, small children, and any patient with significant heart and/or lung disease.
  • Action
    Baxter sent IMPORTANT PRODUCT INFORMATION letters dated April 3, 2014 to all peritoneal dialysis healthcare providers of record. The letters advised healthcare providers of the potential to develop Increased Intraperitoneal Volume (IIPV) and instructed the healthcare providers to complete and return the attached Customer Reply Form. Healthcare providers with clinical questions can contact Baxter's Renal Division Clinical Helpline at 888-736-2543, option 2, 8:00 AM - 5:00 PM CT. Healthcare providers with general questions can contact The Center for One Baxter by telephone at 800-422-9837, Monday - Friday, 8:00 AM - 5:00 PM CT. Additionally, an IMPORTANT PRODUCT INFORMATION letters dated April 8, 2014 were sent to all peritoneal dialysis patients of record. The letters advised patients of the potential to develop Increased Intraperitoneal Volume (IIPV) and instructed the patients to complete and return the attached Home Patient Reply Form. Patients with questions about the letter can contact The Center for One Baxter by telephone at 800-422-9837, Monday - Friday, 8:00 AM - 5:00 PM CT.

Device

Baxter AMIA APD System
  • Model / Serial
    Product Code: 5C9310
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US: Nationwide in the states of (GA, MA, NC, NY, PA, WA)
  • Product Description
    AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA