Events

Recall of Device Recall HomeChoice Automated Peritoneal Dialysis Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Renal Div.

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
    45861
  • Event Risk Class
    Class 2
  • Event Number
    Z-0946-2008
  • Event Initiated Date
    2007-11-20
  • Event Date Posted
    2008-03-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66290
  • 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 Dialysis Systems - Product Code FKX
  • Reason
    Unrecorded infusion; if the system is powered down or a power failure occurs during a fill cycle, the homechoice system may not record the last 1-4 pump strokes infused into the patient when the power is restored. this situation may create a potential unrecorded delivery of approximately 15-60 ml of fluid being infused into the patient.
  • Action
    Urgent Product Recall letters dated 11/20/07 were sent via first class mail to all of the affected customers, informing them of the potential for overfill if the system is powered down or a power failure occurs during a fill cycle. A Baxter representative will contact the customer to schedule the software update which corects this anomaly. The accounts were requested to complete and return the enclosed Customer Reply Form, indicating that they have disseminated the information to their staff and home patients. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 1. Baxter sent a follow-up letter dated 3/17/08 to the consignees, accompanied by a copy of the 11/20/07 letter. The letter reiterated the information in the 11/20/07 letter, emphasizing the serious consequences of an overfill for neonates and young pediatric patients, and providing information describing the symptoms of excess fluid in the abdomen and steps to be taken if the user suspects overfill of a neonate or young pediatric patient. Baxter requested that Baxter be contacted if an overfill should occur so Baxter can perform a complete investigation into the event. The accounts were requested to complete and return the enclosed Customer Reply Form, indicating that they have disseminated the information to their staff and home patients. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 1.

Device

Device Recall HomeChoice Automated Peritoneal Dialysis Systems
  • Model / Serial
    All serial numbers released prior to 09/21/07
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide; USA, Australia, New Zealand, China, Hong Kong, the Philippines, Thailand, Asia, Canada, Algeria, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Malta, Morocco, The Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Ukraine, Latin America and Japan.
  • Product Description
    Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, and T5C4441R, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A
  • Manufacturer
    Baxter Healthcare Renal Div

Manufacturer

Baxter Healthcare Renal Div
  • Manufacturer Address
    Baxter Healthcare Renal Div, 1620 Waukegan Rd Bldg R, Mc Gaw Park IL 60085-6730
  • Source
    USFDA