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Class 2 Device Recall HomeChoice PRO & Yume Plus |
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Date Initiated by Firm |
May 24, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on December 11, 2007 |
Recall Number |
Z-1013-04 |
Recall Event ID |
29161 |
510(K)Number |
K012988
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Product Classification |
unknown device name - Product Code FKX--
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Product |
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 |
All HomeChoice Systems with software versions 8.5 and higher. |
Recalling Firm/ Manufacturer |
Baxter Healthcare Renal Div 1620 Waukegan Rd Bldg R Mc Gaw Park IL 60085-6730
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For Additional Information Contact |
Center for One Baxter 800-422-9837
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Manufacturer Reason for Recall |
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.
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FDA Determined Cause 2 |
Other |
Action |
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. |
Quantity in Commerce |
8,000 units |
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. |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = FKX-- and Original Applicant = BAXTER HEALTHCARE CORP.
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