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Wednesday, March 3, 2010

Class I Recall of Home Dialysis Device

Baxter Healthcare Corporation offers a line of home devices that kidney dialysis patients can use for their own kidney treatments. A person with kidney disease is unable to excrete bodily wastes using the kidneys and traditional dialysis is a long hospital procedure to bypass the kidneys, using a large machine to cleanse the blood of wastes.

Peritoneal Dialysis done at Home

These home devices can dispose of waste products in either of two ways, and one way is called peritoneal dialysis. The abdominal cavity (peritoneum) contains not just the stomach but also the intestines, liver, and spleen. There is a membrane lining it called the peritoneal membrane which is a natural filter in the body. The Baxter HomeChoice and HomeChoice Pro devices use this membrane to clear the body of waste.

A Peritoneal Dialysis (PD) solutions is placed in the peritoneum and the membrane filters waste from the blood into this solution. After several hours, the waste-filled solution is drained from the body and replaced with fresh solution. The patient is trained in how to do this by a qualified nurse, taking five to seven training sessions. The nurse or a doctor can always be contacted quickly by phone if you have any problems.

Increased Intraperitoneal Volume (IIPV) a Problem

A problem has been reported with these HomeChoice and HomeChoice Pro dialysis devices, as they sometimes cause the peritoneum to be overfilled with solution, a condition called IIPV. Baxter has been working on this by:

  • Updating the device’s software to include more alarms and messages for the patient, so that overfilling cannot occur;
  • Improving the device’s labeling; and
  • Offering extra training in how to use the devices.

The peritoneal dialysis devices are being recalled and the FDA has classified this as a Class I recall, the most serious type of recall, because serious injury reports have been received and one patient has died.

IIPV Signs to Watch For

The excess fluid can cause hernias in the patient’s diaphragm, pulmonary edema, acute hypertension, and pulmonary instability. Patients and their caregivers should be alert for:

  • Breathing difficulty
  • Abdominal pain
  • Swelling in the lower abdomen and genital area
  • A bloated feeling
  • A child crying for no obvious reason or complaining of a “funny feeling”

If you notice any of these signs, stop the dialysis immediately and contact your physician. Children are at elevated risk for IIPV because of their smaller body size and reduced margins of error. “Other vulnerable populations include … non-verbal patients … critically ill patients and patients with pulmonary and hemodynamic instability," says Baxter. “Increased monitoring of these patients is recommended.”

When the instructions are properly followed, other HomeChoice devices are “safe and effective”, according to Baxter, and they will remain on the market. You can read more about peritoneal dialysis on Baxter’s website.

Not every kidney patient is a good candidate for home dialysis. It is up to the physician to make a good judgment call and to monitor patients closely, staying in good communication with the home nurse.

If you have been harmed by a drug or medical device, you might have a valid defective product claim or perhaps a medical malpractice claim. To learn more about your legal rights and options, please contact us for a free case review. Our offices are nationwide for your convenience.

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posted by Benjamin A. Irwin at 11:10 AM

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