Model Number 3CX*FX25RWC |
Device Problem
Dent in Material (2526)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2023 |
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.
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Event Description
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The user facility reported to terumo cardiovascular that prior cardiopulmonary bypass, during out of box, the oxygenator has dent.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, 3259, 4307).The returned sample was inspected upon receipt and confirmed a slight indentation on the cr filter.Within the filter is a support piece that attaches to the a-pipe, as well as a defoamer.It is possible that during assembly, the filter was compressed slightly, leaving the cr filter with an indentation.However, this is not a functional issue as the support piece will keep the filter from caving in.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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on january 5, 2024.Upon further investigation of the reported event, the following information is new and/or changed: d9 (device availability - added date returned to manufacturer); g3 (date received by manufacturer) ; g6 (indication that this is a follow-up report) ; h2 (follow-up due to additional information) ; h3 (evaluation is in progress, but not yet concluded, thus code 81).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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