Events

Recall of Device Recall Baxter BM25 System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Renal Div.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    34245
  • Event Risk Class
    Class 2
  • Event Number
    Z-0679-06
  • Event Initiated Date
    2005-12-21
  • Event Date Posted
    2006-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43328
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
  • Reason
    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.
  • 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.

Device

Device Recall Baxter BM25 System
  • Model / Serial
    all serial numbers
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide including Puerto Rico, and internationally to Colombia, Hong Kong and China
  • Product Description
    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
  • Manufacturer
    Baxter Healthcare Renal Div

Manufacturer

Baxter Healthcare Renal Div
  • Manufacturer Address
    Baxter Healthcare Renal Div, 1620 Waukegan Rd Bldg R, Mc Gaw Park IL 60085-6730
  • Source
    USFDA