GranuFlo and NaturaLyte Renal Dialysis Infusate – Case Review – focus blocks

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

Areas focused in Medical Records Review

  • Medical History
  1. Renal Disease History of Patient
  2. Dialysis History
  • Infusate Details
  1. Confirm usage of Granuflo
  2. Usage Details – Dose, Time Period of Usage
  3. Whether Infusate Serial Number included in the FDA Class 1 recall list of 06/27/2012
  4. Serial numbers for Naturalyte GranuFlo (powder) Acid Concentrate range from:
  5. 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
  6. Whether Granuflo usage was continued even after characteristic injury?
  7. Regular Bicarbonate Administration/Usage Detail
  • Injuries/Complications
  • Document Bicarbonate Overdose (Metabolic Alkalosis)
  1. Low BP – Blood Pressure Recordings
  2. High Blood Bicarbonate Levels –
  3. Hypoxemia – Blood Oxygen Levels
  4. 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
  • Missing records notification to Client related to
  • Granuflo Usage Details
  • Adverse Events, Injuries Details
  • Quick Cardiologist Opinion relating the Cardiac Injury/Death to High Bicarbonate Levels/Granuflo Usage can be given if needed

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Published On: February 23, 2021 / Categories: Dangerous Drugs /