Model Number 3CX*RX15RE30 |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/30/2019 |
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 that prior to cardiopulmonary bypass, during setup, the arterial probe was unable to register a temperature reading. no consequences or impact to 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 on (b)(6) 2019. upon further investigation of the reported event, the following information is new and/or changed: date received by manufacturer.Indication that this is a follow-up report.Follow-up due to additional information.Identification of evaluation codes (b)(4).Method code: (b)(4) - device not returned.Results code: (b)(4) - improper physical structure.Conclusions code: (b)(4) - cause traced to component failure.The affected sample was not returned for evaluation.A retention sample was not able to be tested as the affected lot number was not provided.An engineering investigation and capa have been initiated to determined a definitive root cause.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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