MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06 report with the FDA on 2015-02-27 for VKMO 11000 # QUADROX-I NEO. MIT RESERVOIR 70104.9279 manufactured by Maquet Cardiopulmonary Ag.

[5472797] It was reported there was leakage on the sampling manifold during priming. (b)(4). Patient Sequence No: 1, Text Type: D, B5

[13000404] The device is not available for investigation so follow up is not possible. Maquet cardiopulmonary is aware of similar complaints from this product and an internal process (b)(4) was initiated to determine the most probable root cause and to implement the appropriate corrective action. Abbreviation mrb: material review board. Patient Sequence No: 1, Text Type: N, H10