FDA Device

HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R

Hazard

The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice device are not reliably grounded to the device's ground system, posing an electric shock hazard.

What You Should Do

Remedy

Baxter sent Urgent Device Correction letters worldwide to their customers on 6/21/05 and home patients on 6/22/05. The accounts were informed of teh risk of electrical shock from screws used to secure the Power Entry Module to the back of the HomeChoice system, and were instructed to always connect the power cord to the power entry module first, before plugging the power cord into a grounded electrical outlet. The users were advised to use caution to avoid contact the power entry module screws while powering on or powering off the device, and were informed that a new mounting bracket that providews more reliable grounding was installed in instruments processed through the Baxter service organization as of May 2005. All remaining instruments will receive the new mounting bracket by August 2006, and Baxter will contact the accounts to arrange for the upgrade. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 1.

Products

HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441,
Brand
Baxter Healthcare Renal Div
UPC
all serial numbers

Units Affected

52,617 units