Correction made to a1: patient identifier: none (previously submitted as unknown).Correction made to b5: there was no patient involvement (previously submitted as there was no report of patient injury or medical intervention associated with this event).Correction made to d1: brand name: valve set, em2400 (previously submitted as ni).Correction made to d4: catalogue #: h938724 (previously submitted as asku).F10/h6: health effect - impact codes: replace f26 with f27.Correction made to g1: the device was manufactured at one of the following facilities: baxter healthcare - englewood, 14445 grasslands dr, englewood co 80112, united states; availmed, c.Industrial lt.001 mz.105, no 20905 int a, col cd ind., tijuana, baja california 22444, mexico.Correction made to g4: pma/510k #: k002705 (previously submitted as ni).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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