A report was received on (b)(6) 2024 from a healthcare professional (hcp), regarding a critical care patient with unspecified pathology, who stated a cartridge blood leak was observed during a continuous renal replacement therapy (crrt) treatment on (b)(6) 2024.Although requested, no further information was provided.There was no indication of adverse impact to the user or patient and no report of medical intervention being required.
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No product was received for evaluation.All devices must meet quality requirements and manufacturing specifications prior to release.The instructions for use states "check the system for blood and fluid leaks during treatment, and pay close attention to the blood line and access connections." all treatments must be administered under a physician''s prescription and performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician so that alarms and harmful conditions can be responded to promptly.
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