Maquet Cardiopulmonary GmbH, 713001, PLS Set

During internal investigation Maquet Cardiopulmonary GmbH (MCP) has identified that the packaging material (medical paper) of the PLS Set components recirculation line (5) and scissors (14) (see Fehler! Verweisquelle konnte nicht gefunden werden.) is inadequate to maintain the sterile barrier after removal from the primary sterile packaging (open Tyvek on the tray) if not consumed immediately during the priming process. The affected packaging material of accessories might get damaged during the transportation and the damages might remain undetected as they are to small to identify them with naked eye. The recirculation line (5) is used to wean the patient from the extracorporeal circulation (ECMO application) and is required at the end of application after 6 hours / 5 days / 14 days depending on product configuration. The scissors (14) are used in different stages of the application 6h / 5d / 14d depending on product configuration if not consumed immediately after priming. PLS Set itself is delivered sterile and compliant, this non-conformity relates to maintaining sterility after opening the PLS Set and removal of components (5) and (14) from the PLS Set tray for use in a later stage of extracorporeal circulation application.