A product investigation was performed for this device.A visual inspection confirmed there was dried fluid inside the cassette compartment and underneath the mushroom heads.During a stimulated treatment the reported drain complication alarms were verified, due to fluid in the pneumatic system.The device passed the mushroom head inspections.The leak was contributed to the cassette.A device history record review was performed for this device.There was no unexpected variances, or adjustments or comments noted in the device records.A search in the complaint tracking system listed no other drain complications, m31 air in the cassette, or fluid leak complaints for this device.A review was performed by the post market clinical department.Per the pharmacovigilance physician the event of peritonitis is unlikely related to the liberty cycler machine.At the time of the event there were no further fluid leaks or any other machine malfunction.Peritonitis in a patient undergoing peritoneal dialysis is most often due to contamination with pathogenic skin bacteria resulting form touch contamination or catheter related infection.There was also a complaint of chest pain but sufficient information, medical records and treatment sheets were not available for review.It is reported the patient is currently on hemodialysis and is doing well.This is a retrospective mdr being submitted by fresenius medical care as a remediation action committed to fda regarding all potential adverse events received between (b)(6) 2011 to (b)(6) 2013.
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