Baxter Healthcare Renal Div 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.