Model Number 3CX*FX15RW30C |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/25/2017 |
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).Results code: results pending completion of evaluation.Conclusions code: conclusion not yet available-evaluation in progress.
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Event Description
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the yellow cap on top of cardiotomy broke off and the internal portion was still in the port. no patient involvement as this occurred during setup.Product was changed out.Procedure 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.Upon further investigation of the reported event, the following information is new and/or changed: (b)(4).The sample was not returned for evaluation; however, a photo of the damaged/broken cap was provided and confirmed to contain a broken cap.All reservoirs are 100% visually inspected at several points in the production process.The packaging of the product also ensures protection against damage to the caps.It is likely that the cap was damaged by a shock force at some point during the handling of the product; however, when or how this shock force was applied was not able to be determined.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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