Failure Modes and Effects Analysis: Off-Label Use of Alaris Infusion Pump for Cerebrospinal Fluid Subarachnoid Drainage

Abstract

Communicating hydrocephalus is a medical conditionthat occurs when there is an imbalance between production and absorption of cerebrospinal fluid (CSF) resulting in increased intracranial pressure. One treatment for the condition involves draining excess CSF. A custom CSF drainage system was designed by clinical staff from Vancouver Coastal Health. The system uses an infusion pump off-label to drain CSF from a catheter inserted into the patient’s lumbar spine. A Failure Modes and Effects Analysis (FMEA) of the system was conducted to assess the risk of the therapy from an equipment perspective. The FMEA identified thirty-one device hazards. Highest ranked hazards included operating the device without drug-error reduction system controls, operator error resulting in improper system setup, and potential patient harm due to the device controlling flow rate instead of CSF pressure.