Model Number 3CX*FX25REC |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2022 |
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 prior to cardiopulmonary bypass, during prime, there was loss of prime from the arterial connector outlet of the oxygen chamber at the height of the temperature probe.No patient involvement, there was 15 minutes delay, the product was changed out, the surgery 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.Upon further investigation of the reported event, the following information is new and/or changed: d9 (device availability - added date returned to manufacturer).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H3 (device evaluated by manufacturer).H6 (identification of evaluation codes 10, 3259).Type of investigation 10 - testing of actual/suspected device.Investigation finding: 3259 - improper physical structure.The affected sample was inspected upon receipt.Damage was noted on the gas in and out ports and the oxygenator was not securely clipped into the neck assembly.The unit was pressurized with water and was found to leak.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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on december 16, 2022.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date); g3 (date received by manufacturer); g6 (indication that this is a follow-up report); h2 (follow-up due to additional information); h4 (device manufacture date); h6 (identification of evaluation codes 11, 3331, 4114, 4210, 25).Type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 4114 - device not returned.Investigation finding: 4210 - leakage/seal.Investigation conclusions: 25 - cause traced to manufacturing.The affected sample was not returned; however, a video was provided, confirming a leak from the thermistor.A representative retention sample was obtained, and pressure tested to 1100mmhg for 10 minutes, no leaks were noted.A training was conducted with the production associates to make them aware of this event and to ensure that all thermistors, and other components, are properly assembled and inspected on the reservoir and oxygenator.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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