Model Number 3CX*FX25REC |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/25/2020 |
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.For this reason, terumo references evaluation conclusion code 11.(b)(4).
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Event Description
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The user facility reported to terumo cardiovascular that during non clinical activity, an incorrect assembly of oxygenator was received.As per user facility, the label indicates 3cx*fx25rwc (west), but the actual packed oxygenator is a 3cx*fx25rec (east).*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.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 3331, 170, 25).Method code #1: 10 - testing of actual/suspected device.Method code #2: 3331 - analysis of production records.Results code: 170 - manufacturing process problem identified.Conclusions code: 25 - cause traced to manufacturing.The affected sample was inspected upon receipt to confirm the reported 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.This event has triggered a health hazard evaluation and a capa 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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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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on september 11, 2020.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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Search Alerts/Recalls
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