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 05/09/2023 |
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 prime, a leakage at the arterial temperature interface was noticed.Per facility, samples were investigated by hmt and it was found that the affected temperature port of the oxygenator was not connected by hmt.*no patient involvement *the product was changed out *the surgery 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.For this reason, terumo references evaluation conclusion code 11.H6: component code: 4761 - access port.Health effect - impact code: 2645 - no patient involvement.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 1354 - leak/splash.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.
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Event Description
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Leakage at arterial temperature interface.
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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, 706, 25).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation finding: 706 - assembly problem identified.Investigation conclusions: 25 - cause traced to manufacturing.The affected sample was inspected upon receipt.It was noted that the arterial thermistor was not affixed to the oxygenator.However, there was bonding agent noted within the port.A representative retention sample was obtained and visually inspected.The arterial thermistor was bonded to the oxygenator appropriately.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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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 july 6, 2023.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 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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Event Description
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Leakage at arterial temperature interface.
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Search Alerts/Recalls
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