This report is being filed to provide additional information in a.1, a2, a.3, a.4, b.5, h.6, and h.10.Investigation: the device history record was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the event.Correction: terumo bct has implemented a correction for this incident.Manufacturing staff were made aware of this issue and retrained to the appropriate procedures.Corrective action: an internal capa has been initiated to address an increase in reports of trima misassembly of 4-lumen tubing.Root cause: the cause of this defect was related to a misassembly, where the assembler neglected to follow the appropriate manufacturing operating procedure of the disposable set during manufacturing.
|