Recall: Baxter dialysis device over death, serious injury

[okarol]

Wednesday, March 03, 2010
Recall: Baxter dialysis device over death, serious injury


The Chicago Tribune's Bruce Japsen Tuesday reported that Baxter International Inc. is recalling an in-home dialysis device because it has been linked to serious injury reports and at least one death in the last two years.

"The U.S. Food and Drug Administration has classified the action as a Class I recall, the agency's most serious, for Baxter's HomeChoice and HomeChoice Pro peritoneal dialysis cyclers because the device is causing an 'overfill' of fluid in the patient's stomach," according to Japsen's story.

Japsen's story explained that "a Class I recall means the FDA wants the company to address the problems. 'The action has been classified as a Class I recall because of the risk of serious injury or patient death that could be associated with the use of the device,' the company said in a statement."

Baxter published a press release March 2 including the following information (in italics):

The recall notice does not require the physical return of HomeChoice units and patients may continue using them.

Baxter sent recall notices to clinicians and patients informing them of this action and identifying steps that are intended to reduce the harm associated with IIPV. These January 2010 letters contain more detailed information about device usage and are available at www.baxter.com. Customers or patients with questions regarding this notice may contact Baxter 24 hours a day, seven days a week at 1-800-553-6898. Any adverse reactions experienced with the use of this product, and/or quality problems, should be reported to Baxter’s Renal business at 1-888-736-2543, prompt 3, and the FDA's MedWatch Program at 1-800-FDA-1088 or www.fda.gov/MedWatch/report.htm

The medical term for the "overfill" of fluid caused by these devices is Increased Intraperitoneal Volume (IIPV). Baxter's March 2 press release gave a summary of what IIPV is:

IIPV may result in serious injury or death from conditions such as: abdominal wall and/or diaphragmatic hernias, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function and pericardial effusion. Children and non-verbal patients may be at increased risk because of their smaller size and/or inability to communicate. Increased monitoring of these patients is recommended. Other vulnerable populations include critically ill patients and patients with pulmonary and hemodynamic instability.

Possible symptoms of IIPV include:

    * Difficulty breathing
    * Vomiting or spitting up
    * A child complaining of a “funny feeling” in the abdomen
    * A child crying during therapy without other apparent reasons
    * Difficulties feeding
    * Feeling full, bloated, or overfilled after treatment
    * Abdominal pain or discomfort
    * Expanded or tense abdomen
    * Localized swelling around the genital area (labia, scrotum) or groin region, belly button, the tunnel tract of the peritoneal dialysis catheter or the PD catheter exit site
    * Leakage of fluid from the PD catheter exit site
    * Unexpected increase in blood pressure

The press release said the following model numbers are affected by the recall:

    * 5C4471
    * 5C4471R
    * 5C8310
    * 5C8310R
    * 5C4474
    * 5C4474R
    * R5C8320
    * R5C8320R
    * T5C4441
    * T5C4441R
    * T5C8300
    * T5C8300R
    * 5C4474D
    * 5C4474DR

http://newsblogs.chicagotribune.com/the-problem-solver/2010/03/recall-baxter-dialysis-device-over-death-serious-injury.html

[paul.karen]

You posted a story about this Baxter Recall a few months ago.
Funny how they call it a class 1 recall but dont want any machines returned.

About 2 weeks after your posting the original story my unit had me read and sign a pc. of paper stating i have read the warning.  I told them i had known about the recall for over two weeks.

Thx for the good work Okarol