The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the centrifugal pump was running at 3600rpm but only getting flow of 3.5l/m.Per user facility the line pressure was 120 no visible clots in oxygenator or reservoir.Perfusionist waited 30 minutes for backup to arrive before changing out oxygenator.The mean arterial was low 30, so they've thought it was because of the 3.5 flow.The changed oxygenator had better flow parameters but still low mean arterial.The anesthesiologist treated vasoplegia with b-12 and this took care of low map.Blood loss of less than 100 cc.Product was changed out.Procedure was completed successfully.
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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 november 22, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d10 (date returned to manufacturer).G4 (date received 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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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: d4 (additional device information - added expiration date); g4 (date received by manufacturer); g7 (indication that this is a follow-up report); h2 (follow-up due to additional information and device evaluation); h3 (device evaluated by manufacturer); h4 (device manufacture date); h6 (identification of evaluation codes (10, 3331, 213, 67).Method code #1: 10 - testing of actual/suspected device.Method code #2: 3331- analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The actual sample was rinsed, dried and built into a circuit.Bovine blood was circulated in the circuit while pressure drop was determined at each flow rate.The obtain values were confirmed to meet the factory's specifications and the flow rates increased up to maximum flow range the device can provide.No obstruction or clot was found that could lead to increase in pressure in the return sample.As a possible cause, due to clogging occurred in the circuit, flow rate could not be obtained as expected, also the distal end of a cannula was adhering to the vessel wall or there was a kink occurred in tubing, however, since no anomaly was observed the cause of this issue cannot be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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