It was reported that no disposable pump won't run error occurred.Patient switched pump, still received the same error.Patient attached a new cassette to the original pump, which resolved the issue.The patient kept malfunctioning cassette in case she needs to send to manufacturer.No patient injury was reported.
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Catalog number, unique identifier and 510k number are unknown.No information has been provided to date.No lot number was provided; therefore, device history record review could not be completed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
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