November 29, 2012 — Cardiac arrest is a devastating complication of hemodialysis. Hundreds of dialysis cardiac arrests and deaths have been linked to GranuFlo and NaturaLyte, which are products that are added to a dialysis patient’s blood. Unfortunately, improper doses of GranuFlo or NaturaLyte can change the pH of the blood, interfere with electrical activity in the heart, and cause a deadly cardiac arrest.
If you or your loved one suffered a cardiac arrest during dialysis treatment, it is possible that GranuFlo or Naturalyte were involved. The FDA recalled these products in June 2012 after they were associated with at least 941 cardiac arrests and deaths. Unfortunately, the FDA only became aware of the risk in early 2012 after an anonymous source leaked an internal memo from Fresenius Medical Care, the manufacturer of GranuFlo and NaturaLyte.
Fresenius sent the internal memo to their own doctors on November 4, 2011. The memo warned that patients with high bicarbonate levels were up to 8 times more likely to suffer a deadly cardiac arrest. Doctors could reduce a patient’s risk of cardiac arrest by checking their bicarbonate levels before dialysis, and also taking care to measure the proper amount of GranuFlo or NaturaLyte.
Although the memo included important risk information, it was not sent to the FDA, non-Fresenius doctors, or the public. Consequently, many lawsuits have been filed alleging that Fresenius wrongfully withheld side effect information.
Dialysis Cardiac Arrests
Cardiac arrest is the sudden loss of heart function that occurs when the electrical system in the heart malfunctions. The heart chambers stop pumping blood to the body, causing death within minutes. It is different from a heart attack, which occurs when a blockage stops blood-flow to the heart muscle.
Improper doses of GranuFlo and Naturalyte can trigger a sudden, deadly cardiac arrest by changing the chemistry of a patient’s blood. Accidental bicarbonate overdoses can increase the pH of the patient’s blood, causing a condition called metabolic alkalosis, which interferes with heart rhythm.
Symptoms of a Dialysis Cardiac Arrest
Sudden cardiac arrest often occurs without warning. However, patients may exhibit the following symptoms before it occurs:
- Low blood pressure
- Loss of consciousness, fainting, dizziness
- Irregular heart rhythm, heart palpitations
- Low oxygen in the blood
- Lack of a pulse
- Respiratory distress, shortness of breath
- Fatigue, weakness
- Chest pain or discomfort
- And more
Do I have a Dialysis Cardiac Arrest Lawsuit?
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