(b)(4).The device was returned for evaluation.A review of the device logs revealed no system errors, anomalies, hardware device failures or increased intraperitoneal volume (iipv) events that could have caused or contributed to the reported event.The product analysis lab (pal) evaluated the device and no failures or malfunctions were identified that could have caused or contributed to the patient passing away.The device was determined to meet electrical performance specification requirements per return instrument test/ evaluation (rite) testing.The device failed the homechoice rite functional testing, however, it was determined that the failure was unrelated to the reported event.An internal and external inspection was performed and found no issues.An evaluation of the device pneumatic system revealed no leaks and all pressures were correct & stable.The device also passed seal, purge & wet disposable integrity tests.A short simulated therapy was performed successfully.Review of the device service history revealed no issues that could have caused or contributed to the home patient passing away.Upon conclusion of the investigation, no abnormalities or failures were identified that could have caused or contributed to the patient passing away.Should additional relevant information become available, a supplemental report will be submitted.
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