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

  • B. Gribbons Providence Healthcare
  • M. Burmister Providence Healthcare
  • S. Buzikievich Providence Healthcare
  • D. Ho Providence Healthcare
  • S. Hawley Vancouver Coastal Health
  • E. Rose Vancouver Coastal Health
  • M. Fekete Vancouver Coastal Health

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.

Published
2019-05-21
How to Cite
[1]
B. Gribbons, “Failure Modes and Effects Analysis: Off-Label Use of Alaris Infusion Pump for Cerebrospinal Fluid Subarachnoid Drainage”, CMBES, vol. 42, May 2019.
Section
Academic