Model Number CDI510H |
Device Problem
High pH (2426)
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Patient Problem
No Information (3190)
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Event Date 09/29/2020 |
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 during cardiopulmonary bypass, there was a significant ph drift.It is unknown whether the product was changed out, or if there was any effect on the patient or results of the surgery.Due to the unknown information for this event, it is being reported.Terumo continues to attempt to gain more information regarding this event from the user facility.Additionally, as per the subsidiary, the cdi was calibrated 5 minutes after bypass, ten minutes later, the ph climbed to 7.8, and be and hco3 parameters disappeared.
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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 october 16, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 11, 3331, 4114, 3221, 4315).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer; method code #2: 3331 - analysis of production records; method code #3: 4114 - device not returned; results code: 3221 - no findings available; conclusions code: 4315 - cause not established.The affected sample was not returned for evaluation; therefore, a thorough investigation could not be performed.A retention sample was obtained and visually inspected with no anomalies noted.It was calibrated using the cdi 500 and cdi 540, and was successful on the sample.The retention was then circulated with buffer solution and found to produce consistent values on the cdi500 monitor and was found to perform as expected.Without the returned sample, a thorough investigation could not be performed, and a definitive root cause could not 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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