(b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.The complaint is part of a capa (b)(4) and has not been reported due to "old" reporting policies and the oxygenator without coating is not sold in the us.The oxygenator itself, included in the pls tubing set has been glued with the same glue as the types of oxygenators which are sold in the us.The glue was changed in (b)(4) 2013 and the implementation was validated in (b)(4) 2013.Since then no further incidents related to connector detachments with the same root cause are known.A f/u report will not be issued.
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