(b)(4).Address line 1 (b)(6).The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A leak test was performed on the blood side of the device, and revealed no leakage.A leak test was then performed on the dialysate side and revealed a leak from a crack in the welding zone of the header.The cause of the crack was not determined.A batch review was conducted and there were no deviations found during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
|