Events

Recall of HOMECHOICE AUTOMATED PD SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAXTER CORPORATION.

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
    71593
  • Event Risk Class
    II
  • Event Initiated Date
    2013-04-08
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Baxter in conjunction with health canada is providing this notice to reinforce the importance of proper programming to reduce the potential for unintended increased intraperitoneal volume (iipv) or overfill of the abdomen in patients using the homechoice and homechoice pro apd systems. unintended iipv can occur if the prescription parameters are not programmed appropriately in the dialysis systems and this can lead to serious injury or death.

Device

HOMECHOICE AUTOMATED PD SYSTEM
  • Model / Serial
    Model Catalog: 5C4471 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 5C4471R (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 5C8310R (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 5C8310P (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 5C8310 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 5C8310PE (Lot serial: >1000 NUMBERS CONTACT MFR)
  • Product Description
    HOMECHOICE AUTOMATED PD SYSTEM
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION