Skip to content

HomeChoice PRO and Yume PlusAutomated Peritoneal Dialysis… recallZ-1013-04 · Baxter Healthcare Renal Div · initiated May 24, 2004

Terminated All recalls posted in July 2004

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Renal Div or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

A software defect could result in a patient experiencing an overfill with software versions 8.5 and higher. The possibility of an overfill can occur when the Initial Drain Alarm Volume is set to OFF and a change to the volume is made at the Verify I-DRAIN:XXXXML prompt.

FDA root cause category: Other

What the company is doing

Urgent Device Correction letters dated 5/24/04 were mailed to the peritoneal dialysis nurse of facilities identified as having patients who use the HomeChoice machines. The letters informed them of the potential overfill problem and requested that they review the patient list provided with the letter and verify that it was complete. The nurses were requested to communicate the information to their home patients, and visit all of their patients who use the device in the low I-Drain Alarm Volume mode to make an interim correction, permanently changing the I-Drain Alarm Volume from OFF to 0ML in the Make Adjustments menu. Permanent software corrections will be installed when the revised software becomes available. Follow-up letters dated 1/12/05 were sent to the Home Care Coordinators, providing them with an addendum to the HomeChoice Trainer's guide, repeating the information from the 5/24/04 letter and providing additional information to safely disconnect from the HomeChoice system during therapy. The letters also included copies of the 1/14/05 letter sent directly to the HomeChoice home patients, as well as addenda to the Patient Help Cards and Patient At-Home Guide.

Recall details

Recall number
Z-1013-04
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 24, 2004
Posted by the FDA
Jul 20, 2004
Recalling firm
Baxter Healthcare Renal Div
Quantity
8,000 units
Product code
FKX--
FDA submissions
K012988
Distribution
Nationwide, Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Guatemala, Hong Kong, India, Ireland, Italy, Korea, Malaysia, Mexico, Nicaragua, the Netherlands, Peru, the Philippines, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela and the United Kingdom.

Product description

HomeChoice PRO and Yume PlusAutomated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R

Code information (models, lots, serial numbers)

All HomeChoice Systems with software versions 8.5 and higher.

Other devices under the same FDA submission

1 device cleared under K012988 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 29161).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page