Model Number 3ZZ*FX25RECA |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/26/2017 |
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.(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 fx purge line prior to the one way valve was flattened.The purge line had no flow through the tubing unless it was manipulated.No consequence or impact to the patient.Product was not 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.A retention sample from the product code/lot number combination was visually inspected and no issues were noted.All reservoirs with purge line were 100% visually inspected multiple times during manufacturing process and prior packaging.It is not known how and when this damage could have happened.However, it is likely that the affected unit may have been damaged sometime after packaging at tcvg and prior receiving by the customer.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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