The cartridge was discarded and not received for evaluation.A device history record (dhr) review was conducted for the reported lot number and confirmed the product was released for distribution having met quality and manufacturing specifications and requirements.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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A report was received on 22 feb 2024 from a 58 year old female patient with a medical history including diabetes and end stage renal disease, who stated a blood leak was observed during a home hemodialysis treatment on (b)(6) 2024.Additional information was received on 27 feb 2024 from the home therapy nurse (htn) who stated the patient experienced a decrease in blood pressure (nos) and unspecified bloodwork was performed.There was no report of medical intervention and following the event, the patient continues to treat with the nxstage system.
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