The cartridge was discarded by the user and was not available for evaluation.A lot number for the cartridge was not provided.Without a lot number, a review of the device history record (dhr) could not be performed.Log files from the hemodialysis cycler were provided and analyzed for the event which confirmed the system was functioning as designed with alarms and cautions generated according to specifications.The available information does not indicate a device malfunction occurred.The instructions for use (ifu) warn that the cartridge has multiple connection points, and failure to make the proper connections can cause compromised treatment, blood loss, injury or death.The ifu outlines methods to reduce the risk of fluid or blood leaks, or accidental disconnections.A trained and qualified observer must check the system for blood and fluid leaks during treatment, pay close attention to the blood line and access connections, and keep vascular access sites and all cartridge connections visible throughout the treatment.
|