http://www.yourlawyer.com/topics/overview/Baxter_Meridian_Hemodialysis Sat, 21 Nov 2009 13:48:43 -0800 pixel-app en http://www.yourlawyer.com/articles/read/13717 Mon, 21 Jan 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13717 Heparin, and one death at a Florida hospital could be linked to the Baxter Heparin recall.  

According to the Baxter Heparin recall notice, a variety of reactions have been reported in relation to the recalled Heparin, including abdominal pain, abdominal pain (upper), decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, lacrimation increased, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, paresthesia (oral), pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli.

Involved in the Baxter Heparin recall are nine lots of Heparin Sodium 1000 unit/mL for injection.   They include:

•    NDC# 0641244045, Lot #107054 , Heparin 1000units/mL 1OmLvial, expiration date 10/2009
•    NDC# 0641244045, Lot# 117085, Heparin 1000units/mL 1OmLvial, expiration date 11/2009;
•    NDC# 0641245045,  Lot# 047056, Heparin 1OOOunits/mL30mL vial, expiration date 10/2008
•    NDC#0641245045, Lot# 097081, Heparin 1OOOunits/mL30mL vial, expiration date  09/2009
•    NDC#0641245045, Lot# 107024, Heparin 1OOOunits/mL30mL vial, expiration date  10/2009
•    NDC# 0641245045, Lot# 107064 Heparin 1OOOunits/mL30mL vial, expiration date 10/2009
•    NDC# 0641245045, Lot# 107066 Heparin 1OOOunits/mL30mL vial,  expiration date 10/2009
•    NDC# 0641245045, Lot# 107074 Heparin 1OOOunits/mL30mL vial, expiration date  10/2009
•    NDC# 0641245045, Lot # 107111 Heparin 1OOOunits/mL30mL vial, expiration date 10/2009

This is not the first time that Baxter’s Heparin vials have caused problems.  The Food & Drug Administration (FDA), in collaboration with Baxter, issued a two-page safety alert in February 2007 warning of the fatal dangers of mistaking high 10,000 unit and low 10 unit dose vials of Heparin. The memo advised hospitals to double-check their inventory to ensure dispensing errors do not occur.  The 2007 alert was issued after three infants died in Indiana after they were mistakenly given adult doses.  In December, actor Dennis Quaid and his wife named Baxter in a lawsuit after their newborn twins were mistakenly given potentially fatal overdoses of heparin because of a vial mix up.  In addition to the Quaid twins, at least six newborns and two other patients are known to have received an overdose of heparin since 2001.

According to the Baxter recall notice, no deaths have been reported in connection with the recalled Heparin vials.  However, on Friday, a Florida TV station reported that one patient had died, and four others had suffered reactions that could be linked to the recalled Baxter Heparin. An official at HealthPark Medical Center in Lee County Florida told nbc2.com that they had removed all of the Baxter Heparin from the facility.  State and Federal authorities are investigating the incident, and according to the report, Baxter is expected to visit the facility this week to see if the patient’s death and the other reactions were linked to the recalled Heparin.  

]]> http://www.yourlawyer.com/articles/read/11047 Wed, 14 Dec 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11047
Baxter, which sent an urgent recall letter to customers in September with instructions on how to address the issue, also said federal regulators have classified the letter as a Class 1 recall, the most serious kind.

The device is used to treat patients with kidney problems.

The problem relates to how tubing sets are routed through clips mounted on the front of the Meridian devices. If routed incorrectly, they can kink or bend, which can result in broken blood cells and cause serious injury or death.

The U.S. Food and Drug Administration's recall classification doesn't require the return of Meridian instruments in the market, Baxter said. Roughly 2,100 of the instruments are in use, including 1,700 in the United States.

Baxter said that to help customers address the problem, in September it provided labels to be attached to the Meridian units and asked that all care providers be trained in the proper setup and monitoring of the devices.

In July, Baxter said it would no longer make any hemodialysis instruments, and the company has been working to transition customers to alternate hemodialysis instruments through a distribution arrangement with Gambro Renal Products.

The last Meridian instrument was made in 2002.]]> http://www.yourlawyer.com/articles/read/11061 Sat, 01 Jan 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11061
The hemolysis is caused by kinking in the blood tubing sets used with the Meridian. This has contributed to one death and one serious injury.

The affected devices are all Meridian Instruments with model numbers 5M5576 and 5M5576R. There are over 2,800 units currently in use, with approximately 2,100 devices in the United States. Users of the Meridian do not have to return the product to Baxter.

This week, Baxter notified its customers about the problem and today FDA is issuing this notification to ensure broad dissemination of the information to health care professionals. FDA also is notifying users that the results of the agency's own analysis and laboratory testing have confirmed the problem with blood line kinking and hemolysis.

Baxter is instructing users to route blood tubing through only one channel of the two channel clips mounted on the front of the Meridian to reduce the chances of kinking. This means that users should clamp the tubing in only one place, not two, to avoid causing hemolysis. (The original labeling for the device instructs users to route the blood tubing sets through both channels of the two-channel clips.) The firm also is instructing users to continuously verify by visual inspection that the tubing is not kinked.

The firm first notified its users about the problem in an "Urgent Product Recall" letter dated September 28, 2005. The notification included diagrams and labels to be placed on the Meridian instrument, displaying the correct use of the clips. The firm will be providing users with modified tubing clips to correct the problem. FDA is working with the company to ensure that the modified tubing clips are available as soon as possible.

Baxter's letters to customers are available on its website at www.Baxter.com. Consumers who have questions about the recall may contact Baxter Healthcare at 1-800-422-9837. Those who have technical questions may contact Baxter Healthcare at 1-800-553-6898.

Physicians or patients who have experienced problems with these devices should report to FDA's MedWatch program and to Baxter. See www.fda.gov/medwatch/ for filing information or call 1-800-FDA-1088 (1-800-332-1088).
]]> http://www.yourlawyer.com/topics/overview/Baxter_Meridian_Hemodialysis Sat, 01 Jan 2005 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/Baxter_Meridian_Hemodialysis Baxter Meridian Hemodialysis

Baxter International announced that due to tubing-related problems, one person died and another person was seriously injured after their blood was damaged during treatment with its Meridian Hemodialysis device. The device is used to treat patients with kidney problems.

Baxter sent an urgent recall letter to customers in September with instructions on how to deal with the issue, also said federal regulators have classified the letter as a Class 1 recall, the most serious kind. The problem relates to how tubing sets are routed through clips mounted on the front of the Meridian devices. If routed improperly, they can bend or get knotted up, which can result in broken blood cells and cause serious injury or death.

The U.S. FDA’s recall classification doesn't require the return of Meridian instruments in the market, Baxter said. Roughly 2,100 of the instruments are in use, including 1,700 in the United States.The last Meridian instrument was made in 2002.

If you or a loved one suffered injuries from Baxter Meridian hemodialysis device, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.]]>