Granuflo Case Evaluation Criteria

Lawsuit Focus – Failure to Warn

Granuflo a renal dialysis additive used to evenly distribute electrolytes during dialysis contains an active ingredient (sodium diacetate) that bodily readily converts to bicarbonate. This along with the regular bicarbonate given to dialysis patients cause high bicarbonate levels that result in bicarbonate overdosage resulting in low blood oxygen leading to cardiac arrhythmia, cardiac arrest and death

Medical History

Renal Disease History of Patient
Dialysis History

Infusate Details
Confirm usage of Granuflo
Usage Details – Dose, Time Period of Usage
Whether Infusate Serial Number included in the FDA Class 1 recall list of 06/27/2012

Serial numbers for Naturalyte GranuFlo (powder) Acid Concentrate range from:
OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-38, OFD2220-3B, OFD2223-3B, OFD2225-3B,
OFD2231-3 B, OFD2251-3B, OFD2301-3B, OFD2323-3 B, OFD2325-3B, OFD3201-3B, OFD3231-3B,
OFD3251-3B, OFD3301-3B

Whether Granuflo usage was continued even after characteristic injury?
Regular Bicarbonate Administration/Usage Details

Injuries/Complications

Document Bicarbonate Overdose (Metabolic Alkalosis)
a. Low BP – Blood Pressure Recordings
b. High Blood Bicarbonate Levels –
c. Hypoxemia – Blood Oxygen Levels
d. Hypercapnia – Blood CO2 Levels

Graphical Timeline showing levels of Oxygen, Co2, Bicarbonate, BP etc can be given if needed

When adverse effects/injuries first noticed/reported
Do Medical Records documenting Granuflo usage with the adverse events
Care and Management of Adverse Effects
Characteristic Injuries: Cardiac Arrhythmia, Heart Attack, Stroke, Sudden Death
Reason for Death – noted in Autopsy Report/Death Certificate

For opining that Granuflo and its bicarbonate levels resulted in a characteristic injury i.e. cardiac arrest, death the following records are needed:

1. Records to Document Granuflo usage – Dialysis Records, any notes mentioning usage of Granuflo for dialysis, physician prescribing bicarbonate

2. Medical History of Heart Diseases, Stroke 2 of 2 2 of 2

3. Complete Set of Medical Records after reporting complication, hospital admission, diagnosis of metabolic alkalosis, treatment, care and management

4. Labs: To document bicarbonate levels, oxygen and CO2 saturation, and other important values.

Accordingly you will need the following:

1. Complete Set of Medical Records for Hospital Admission with complaints of Metabolic Alkalosis – including CPR, Code Blue Sheet, labs

2. Death Certificate, Autopsy Report (if applicable)

3. Prior Records of Dialysis, Medical History Quick Cardiologist Opinion relating the Cardiac Injury/Death to High Bicarbonate Levels/Granuflo
Usage should be obtained