H10: the device was evaluated onsite by a hospital engineer and found a liquid leak from the silicon connector from the degassing chamber that was cracked.The engineer replaced the silicon connector and degassing chamber, adjusted (calibrated) the ultrafiltration cell and variable flow.A simulation and functional test was performed and the device passed.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
|