Model Number 3CX*RX25RE |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/08/2022 |
Event Type
malfunction
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Event Description
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, noticed a nickel size air bubbles over whelm the af125 filter.As per sales, the perfusionist was conducting checklist sop and initiated a stop pump procedure to confirm it was working.As a result the rx25re had nickel size air bubbles over whelm the af125 filter.The perfusionist was concerned and redid the stop function same results.No patient involvement.Product was changed out.Procedure was completed successfully.
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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.
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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 march 25, 2022.Upon further investigation of the reported event, the following information is new and/or changed: 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: d4 (additional device information - added lot number and exp date) g3 (date received by manufacturer) g6 (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) type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 3331 - analysis of production records investigation findings: 213 - no device problem found investigation conclusions: 67 - no problem detected the returned sample was visually inspected with no anomalies that could lead to the air mixing.After rinsing the actual sample, the blood channel was filled with colored saline solution, the blood outlet port side was clamped , and air pressure of 2kgf/cm2 was applied into the blood channel to check the leakage.No leakage was found.A simulation test was then performed using the product of the involve product code.The roller was suddenly stopped while circulating the colored saline solution at a flow rate of 5l/min.As a result, it was confirmed that the pressure inside the oxygenator became negative approximately -20mmhg, measure on the sampling line, and the air was mixed into the oxygenator.As a possible cause form the simulation test, it is likely that the pressure inside the oxygenator became negative and air was drawn in though the fiber when the roller pump was suddenly stopped.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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