Model Number 3CX*FX25REC |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2022 |
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 reported to terumo cardiovascular that during cardiopulmonary bypass, there was a crack on top of the reservoir near the venous inlet.Per facility, towards the end of the case they heard a noise near the inlet of centrifugal pump.No known consequence or impact to patient.The product was not changed out.The surgery was completed successfully.
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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 march 29, 2022.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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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, 11, 3331, 3259, 4307).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation finding: 3259 - improper physical structure.Investigation conclusions: 4307 - cause traced to component failure.A representative retention sample was inspected to confirm no damage to the unit specifically with the reservoir lid.All capiox units are 100% visually inspected at several points in the production process.It is most likely that the damage occurred at some point during the handling of the product; however, when or how this damage occurred was not able to be determined.
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Search Alerts/Recalls
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