Model Number 3CX*FX25REC |
Device Problem
Misassembled (1398)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/26/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).
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Event Description
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The user facility reported to terumo cardiovascular that during an out of box, an incorrect oxygenator assembly was received.No patient involvement.
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Manufacturer Narrative
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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 september 11, 2020.Upon further investigation of the reported event, the following information is new and/or changed: 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.
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Event Description
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On october 30, 2020, terumo cardiovascular systems issued a field removal, 1124841-10/30/2020-002-r.
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Manufacturer Narrative
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This follow-up report is submitted due to terumo cardiovascular systems issuing a field removal, 1124841-10/30/2020-002-r.This follow-up report is submitted to fda in accord with applicable regulations.Method code #1: 10 - testing of actual/suspected device.Method code #2: 3331 - analysis of production records.Results code: 706 - assembly problem identified.Conclusions code: 25 - cause traced to manufacturing.The affected samples were inspected upon receipt to confirm the event.Root cause analysis activities have identified associate error/failure to follow procedure as the immediate cause of the configuration mix-up.An associate provided the incorrect configuration of oxygenator to the assembly line by choosing the wrong tote of product from a staging area and then didn't detect the error during downstream visual inspection.Capa 8d-01225 is in process and will identify stronger controls for tote selection and downstream verification will be managed via engineering controls.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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Search Alerts/Recalls
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