Baxter HomeChoice/HomeChoice Pro 의 리콜

Recall

66606

Class 2

Z-2609-2016

2013-10-07

Terminated

United States

2016-12-23

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122712

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.

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 a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, to forward the communication to all customers who may have received these products. Clinical questions should be addressed to Baxter's Renal Division Clinical Helpline at 888-736-2543, option 2 (Monday - Friday, 8:00 AM - 5:00PM CST). General questions about this recall should be addressed to The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CST).