Model Number 3CX*FX15RW30C |
Device Problem
Coagulation in Device or Device Ingredient (1096)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 04/14/2019 |
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 during brand testing, a clotting was noted in the cardiotomy reservoir of a cec circuit.No other information was provided about the nature of the issue.Terumo continues to attempt to gain more information regarding this event from the user facility.
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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: (identification of evaluation codes (11, 3331, 4114, 3221, 67).Method code #1: 11 testing of device from same lot/batch retained by manufacturer.Method code #2: 3331 analysis of production records.Method code#3: 4114 device not returned.Results code: 3221 no findings available.Conclusions code: 67 no problem detected.The affected sample was not returned, so a thorough investigation could not be performed.A representative retention sample from the same lot number was obtained, no visual anomalies noted.The retention sample was tested for clotting with bovine blood for one hour with no clotting observed in the cardiotomy portion of the reservoir.It is likely that patient conditions or inadequate heparinization of the patient contributed to the formations of clots within the reservoir filter but without a returned device definitive root cause could not be determined.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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New information was received indicating that the issue occurred during cardiovascular bypass.The surgery was completed successfully, however it is still unknown if there was a delay, if the product was changed out or if there was blood loss.
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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 june 28, 2019.Upon further investigation of the reported event, the following information is new and/or changed: b3 (updated date of event).B5 (describe event or problem).D5 (updated operator of device).E1 (added initial reporter).E4 (updated if initial was sent to fda).G3 (updated report source).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).H6 (updated patient code).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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Search Alerts/Recalls
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