Model Number 3CX*FX15RE30C |
Device Problem
Coagulation in Device or Device Ingredient (1096)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2021 |
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.
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Event Description
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The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was a build up of fibrin on the left side of the membrane.Per facility, they have confirmed through their lab that the build-up post filter was primarily platelets.No consequences or impact to patient.The product was changed out.The surgery was completed successfully.
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Event Description
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New information received indicating that the customer confirmed through their lab that the build-up post filter was primarily platelets.
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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 december 30, 2021.Upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information & correction).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code11.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 to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date and udi number).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H4 (device manufacture date).H6 (identification of evaluation codes 3331, 4114, 3221, 4315).Type of investigation: #1: 3331 - analysis of production records.Type of investigation #2: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The actual sample was not returned.The provided images at the time of the occurrence confirmed the event.Based on the information from the customer, they confirmed that through their lab, the post filter was primarily platelets.It was inferred that the white substance was the white blood clot generated by blood properties at the time of use.However, since it was not possible to investigate the actual product, it was also not possible to clarify the cause of the white substance and its causal relationship.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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