The returned cartridge was evaluated and confirmed a break in the venous line luer.A device history record (dhr) review was conducted for the reported lot number and revealed the product was released for distribution having met quality and manufacturing specifications and requirements.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.The instructions for use states "make sure mated luer-connectors are secure but do not over-tighten, especially when connections are wet.".
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