Complaint is not confirmed.One unpackaged ar-6485 dualwave arthroscopy fluid management system was returned for investigation.The returned device was assembled with a new ar-6411/ar-6421 arthroscopy pump tubing.Upon functional testing, the pump was turned on and tested under normal use conditions to find if the issue reported could be reproduced, and no issues were found with the device.The device worked as required.No problem found.A clamping test was performed as defined in the user guide (dfu-0212 rev 1 ¿ section 5.2) to simulate an overpressure failure on the pump and to verify if an error message and/or audible alarm would be triggered.The results of the clamp test indicate that the pump triggered an alarm, and the rollers did stop moving.This behavior is expected.Pressure fault test, when the pressure was artificially lowered by removing the inlet from the fluid source, an alarm was triggered, and the device stopped.This behavior is expected.Functional testing with the pressure calibrator found no pump pressure issues.The pump was supplied with 100mmhg and 200mmhg of pressure and displayed the correct reading for each.No problem found.Visual evaluation found that the inflow roller housing door had cracked.The review of complaint records for serial number (b)(6) shows that the device has no previous complaints.The original warranty seal was present and completed.The manufacturing date of the device is 2017-06-21.No problem found.Refer to investigation photos.Complaint is not confirmed.
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