The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: the file has been assessed for the necessity of performing a clinical investigation on a reported hospitalization.On (b)(6) 2019, this patient on peritoneal dialysis contacted customer and reported she had not used the cycler since (b)(6) 2019 and was currently experiencing a drain line is blocked message with the liberty select cycler.The cycler was processed for replacement during the call.There were no reported issues with any fresenius device or product in relation to the hospitalization during the call.During follow-up, the pd nurse reported the patient¿s hospitalization had nothing to do with any aspect of pd treatment.The nurse declined to provide any additional information.Reportedly, the patient has been completing pd treatments while waiting for the cycler without any reported issues.Currently, there is no allegation or any objective evidence that any fresenius device(s) caused or contributed to a serious adverse patient outcome.Therefore, the completion of a clinical investigation is not warranted at this time.Should additional information become available regarding a serious adverse event experienced by a patient and/or user related to a fresenius device(s) and/or product(s), please re-submit for a clinical investigation review and the need for a clinical investigation will be re-evaluated accordingly.
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