The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the oxygenator had a yellowish line running through the fiber bundle.No patient involvement as this occurred during setup.The product was changed out.The surgery was completed successfully.
|
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on july 28, 2020.Upon further investigation of the reported event, the following information is new and/or changed: d10 (device availability - added date returned to manufacturer); g4 (date received by manufacturer); g7 (indication that this is a follow-up report); h2 (follow-up due to additional information); h3 (device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|
This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 11, 3331, 170, 25).Method code #1: 10 - testing of actual/suspected device, method code #2: 11 - testing of device from same lot/batch retained by manufacturer, method code #3: 3331 - analysis of production records, results code: 170 - manufacturing process problem identified, conclusions code: 25 - cause traced to manufacturing.The actual sample was visually inspected was disassembled to separate the filter.Visual inspection of the actual filter sample found that the discoloration had occurred on the thermal welding area.No discoloration was observed on the fiber located underneath the thermal welding area of the filter.A current product was sample was disassembled and then, the filter was separated and compares with the actual filter sample.As a result, no difference was observed between them.The discoloration spot of the actual sample was subjected to component analysis by ft-ir and confirmed that it had ir spectra very similar to that of the filter of the current product sample.Review of the manufacturing record and incoming inspection record of the involved material code/lot combination confirmed that there was no anomaly in them.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|