It was reported that the patient reported nausea, diarrhea, and headache.Additionally, patient had no disposal message on both of the pumps when using the same cassette.Patient was off her iv remodulin for 20-30 minutes.Patient made a new cassette and attached to pump and it was running normal as expected.No medical or surgical intervention was reported.
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No lot number was provided; therefore, device history record review could not be completed.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.Udi and catalog are unknown.No product information has been provided to date.
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