Hazard description
Under extended clinical use conditions (e.g., long-duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter (part of MPP T/PC tubing set) and pressure sensors. Accumulated moisture may affect airflow or pressure measurement performance if not properly removed. Water ingress in the air compressor can cause inaccurate pressure readings, resulting in excess fluid being administered to the patient than what is indicated by the system, which can lead to patient water intoxication. The issue is only related to Solar GI systems that have water perfusion capabilities.
RecallTracker