Recall Z-2609-2016 · FKX System, Peritoneal, Automatic Delivery

Baxter Healthcare Corp.

1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treat

Date	Oct 7, 2013
Status	Terminated
Reason	In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but cannot bypass, the active Initial Drain. This is to mitigate against Unintended Increased Intraperitoneal Volume (IIVP). This can cause serious problems in patients with unrelated a co-morbid condition of ascites.
Root cause	Labeling design
Action	An IMPORTANT PRODUCT INFORMATION letter dated October 7, 2013, was sent to all affected customers. The letter included instructions for clinicians to: 1) be aware that HomeChoice will attempt to drain the patient to empty at the beginning of therapy (Initial Drain); 2) review HomeChoice instructions for use for additional details on HomeChoice 10.4 Initial Drain Logic; 3) acknowledge your receipt of the notification by completing the attached Customer Reply Form and returning by fax to either 224-270-5457 or scanning and e-mailing it to fca@baxter.com; 3) if the recipient of the letter is
Quantity	* 1) Product Codes 5C4471 and 5C4471R: Approximately 48,600 units; * 2) Product Codes 5C8310 and 5C8310R: Approxiamt
Distribution	Worldwide distribution. US nationwide including Puerto Rico; Australia, Canada, New Zealand, and Japan
FDA record	Open on fda.gov

510(k) clearances named in this recall

K102936

HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R
Baxter Healthcare Corp, Mar 30, 2011