Model Number 3CX*FX25RWC |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/17/2019 |
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 during cardiopulmonary bypass, there was a differential between the venous temperature and the swan-ganz.No consequences 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 on may 20, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d10 (device availability - added date returned to manufacturer), g4 (date application evaluated by manufacturer) , g7 (indication that this is a follow-up report), h2 (follow-up due to additional information), 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, 213, 67).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The two returned samples were visually inspected, during which no anomalies were noted.A terumo corporation (japan) fx15 oxygenator/reservoir sample was obtained as well as a tcvs representative retention sample.No anomalies were noted with any units.The four samples were set up in a series and water was circulated through the units.Temperatures were taken from each of the samples at room temperature, warm temperature, and a cooled down temperature, once steady state was achieved at each level.There were no temperature differences between any of the samples at any water condition.The venous inlet ports were then cut out to measure the relative depth of the installed thermistor.Evaluation of the returned samples compared against the retention samples found that there was no difference between the temperature readings.The reported event was not able to be replicated and the complaint was not confirmed.It is known that there can be variability in the depth that the thermister reaches within the oxygenator port, this variability exists in both the elkton manufactured oxgyenators as well as the tc manufactured oxygenators.In addition, if temperatures are taken at two separate locations and then compared, the variability in the fluid may cause the temperatures to truly be different at these different locations.If temperatures are read at a time that the fluid is being warmed or cooled, and a steady state temperature is not achieved prior to measuring this temperature, this will also cause a difference in readings.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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