Model Number 3CX*FX15RW40C |
Device Problem
Increase in Pressure (1491)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 04/21/2022 |
Event Type
Injury
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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, the oxygenator developed increasing pre membrane pressures.There was a 200ml blood loss.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 on may 6, 2022.Upon further investigation of the reported event, the following information is new and/or changed: g6 (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, 3331, 213, 67).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation finding: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The actual sample was visually inspected upon receipt and did not find any anomaly such as breakage that could lead to the increasing of pressure.After rinsing and drying the sample, it was installed into a circuit consisting of tubes, and the pressure drop when circulating bovine blood at a flow rate of 5l/min was measured.It was confirmed to meet the factory's specification and no obstruction was found.Saline solution was flowed in the blood channel.No blood clot that led to the increasing of pressure was formed.Review of the manufacturing history record and the incoming inspection record of the actual sample confirmed that there were not any indications of anomaly in the them.A search of the complaint file found no other similar report with the involved product code/lot# combination.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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