TY - JOUR AU - Gribbons, B. AU - Burmister, M. AU - Buzikievich, S. AU - Ho, D. AU - Hawley, S. AU - Rose, E. AU - Fekete, M. PY - 2019/05/21 Y2 - 2024/03/28 TI - Failure Modes and Effects Analysis: Off-Label Use of Alaris Infusion Pump for Cerebrospinal Fluid Subarachnoid Drainage JF - CMBES Proceedings JA - CMBES Proc. VL - 42 IS - 0 SE - Academic DO - UR - https://proceedings.cmbes.ca/index.php/proceedings/article/view/857 SP - AB - <p>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.</p> ER -