Events

Recall of Baxter HomeChoice/HomeChoice Pro

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
    66606
  • Event Risk Class
    Class 2
  • Event Number
    Z-2609-2016
  • Event Initiated Date
    2013-10-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122712
  • 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
    Peritoneal system automatic delivery - Product Code FKX
  • Reason
    In systems with version 10.4 software initial drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). the operator can stop, but cannot bypass, the active initial drain. this is to mitigate against unintended increased intraperitoneal volume (iivp). this can cause serious problems in patients with unrelated a co-morbid condition of ascites.
  • Action
    An IMPORTANT PRODUCT INFORMATION letter dated October 7, 2013, was sent to all affected customers. The letter included instructions for clinicians to: 1) be aware that HomeChoice will attempt to drain the patient to empty at the beginning of therapy (Initial Drain); 2) review HomeChoice instructions for use for additional details on HomeChoice 10.4 Initial Drain Logic; 3) acknowledge your receipt of the notification by completing the attached Customer Reply Form and returning by fax to either 224-270-5457 or scanning and e-mailing it to fca@baxter.com; 3) if the recipient of the letter is a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, to forward the communication to all customers who may have received these products. Clinical questions should be addressed to Baxter's Renal Division Clinical Helpline at 888-736-2543, option 2 (Monday - Friday, 8:00 AM - 5:00PM CST). General questions about this recall should be addressed to The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CST).

Device

Baxter HomeChoice/HomeChoice Pro
  • Model / Serial
    *** 1) HomeChoice automated peritoneal dialysis system:  Product Codes: 5C4471 and 5C4471R;  Serial Numbers: All serial numbers;   *** 2) HomeChoice Pro automated peritoneal dialysis system:  Product Codes: 5C8310 and 5C8310R;  Serial Numbers: All serial numbers
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide including Puerto Rico; Australia, Canada, New Zealand, and Japan
  • Product Description
    1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. || 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. || The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
  • 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