Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted. clinical review: based on the information available, the liberty select cycler is disassociated from the event, as there is no allegation or objective evidence indicating a fresenius product deficiency or malfunction caused or contributed to the patient¿s hospitalization.Furthermore, to the knowledge of this reviewer, the patient continues to utilize the same liberty select cycler without any reported issues or allegations of machine malfunction or deficiency.
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