Class 2 Device Recall Baxter BM25 System

• Date Initiated by Firm: December 21, 2005
• Date Posted: March 29, 2006
• Recall Status: Terminated on June 23, 2008
• Recall Number: Z-0679-06
• Recall Event ID: 34245
• 510(K)Number: K974652
• Product Classification: Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
• Product: Baxter BM25 System ultrafiltration hemodialysis machine; The BM25 System is composed of a BM11A Blood Monitor Pump (5M3051/5M3051R) and a BM14 Ultrafiltration Monitoring Module (5M3052/5M3052R), with a cart with scales (5M3053); Baxter Healthcare Corporation, Deerfield, IL 60015; product code GEF042-10 in China
• Code Information: all serial numbers
• Recalling Firm/ Manufacturer: Baxter Healthcare Renal Div; 1620 Waukegan Rd Bldg R; Mc Gaw Park IL 60085-6730
• For Additional Information Contact: Center for One Baxter ; 800-422-9837
• Manufacturer Reason for Recall: Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubing sets to be used with the BM11/BM11A Blood Monitor Pump and BM25 System ultrafiltration hemodialysis system.
• FDA Determined Cause: Other
• Action: Important Product Information letters dated 12/21/05 were sent to all BM-series instrument users, informing them of the potential for kinking of the tubing if the hemofilter is in the vertical position and the compatibility testing conducted on certain blood tubing sets for use with the BM-series instruments and Baxter''s recommendation that the following sets be used with the BM-series instruments: a) product code 5M3006M for use with the BM 11 and the BM 11a, when the BM 11a is used as a stand alone device; b) product code 5M3048 for use with the BM 11a when operated as part of the BM 25 System; and c) product code 5M3046 for use with the BM 14 part of the BM 25 System. Please note that the BM 14 cannot be used as a stand alone instrument. A fourth bloodline manufactured by Nextron and identified as a BM11 Low Volume Tubing (Baxter product code 5M3132 and Nextron code DHZ0006) was found to be unqualified for use for the BM series instruments. A recommended blood tubing sets and setup guide with diagrams was included with the letter. Both the letter and the setup guide contained the following warning: ''During machine set up, verify that the selected blood tubing set has been recommended for use with the Baxter bm11/bm11a Blood Monitor Pump and the Baxter bm25 System. Using non-recommended blood tubing sets, even if the blood tubing set fits and appears to function correctly, may have clinical consequences. These consequences may include blood tubing kinking, which may cause hemolysis. Clinical consequences of returning hemolyzed blood to a patient range from back pain and shortness of breath up to and including death.'' The users were also informed that the warning was being included in a new revision of the Operator''s Manual, and were requested to call Baxter''s Center for Service at 1-888-229-0001 to return any stocks of product code 5M3132 for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837.
• Quantity in Commerce: 409 units
• Distribution: Nationwide including Puerto Rico, and internationally to Colombia, Hong Kong and China
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = KDI and Original Applicant = BAXTER HEALTHCARE CORP.