Manufacturer's investigation conclusion: a specific cause for the reported infection could not be conclusively determined.Additionally, a direct correlation between the reported events and the centrimag device could not be conclusively established through this evaluation.It was reported that the patient was experiencing atrial fibrillation and was treated with antiarrhythmic medication.The patient returned to normal sinus rhythm on (b)(6) 20221.A tracheal aspirate performed on (b)(6) 2021 revealed an infection that was treated with antibiotics.The infection resolved on (b)(6) 2021.In addition, the patient experienced intensive care unit (icu) delirium and refused to wear a nasal cannula or continuous pulse oximeter.The patient was treated with an antipsychotic medication and returned to baseline on (b)(6) 2021.The patient was discharged on (b)(6) 2021.Multiple attempts were made to obtain additional information from the customer regarding the centrimag pump return status; however, no additional information was provided.The centrimag device has not been returned for evaluation at this time.The us (united states) centrimag blood pump instructions for use (ifu) lists cardiac arrhythmia, infection, and psychiatric episode as adverse events that may be associated with the centrimag circulatory support system.The lot number or other identifying information of the product was not reported and was not able to be determined during the investigation.No further information was provided.The manufacturer is closing the file on this event.
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