TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VALVE, O.P.S BULK, N-S FOR TC; OVERPRESSURE SAFETY VALVE
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Model Number LN130BJ |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/21/2023 |
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.For this reason, terumo references evaluation conclusion code 11.Component code: 541- safety valve.Health effect ¿ impact code: 2199- no health consequences or impact.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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The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was a safety valve leakage.As per the subsidiary, in the final stage of the surgery, blood was found to be leaking from the safety valve.As the amount of leakage was small, the valve was used as it was, and the surgery was successfully completed.No known consequence or health impact to patient.Product was changed out.There was a less than 1 ml of blood loss.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.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added 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 affected sample was visually inspected upon receipt, with no anomalies noted on the device.Ops valves are subject to a 100% leak test, which includes five different tests the units are run through to ensure there are no leaks and both the umbrellas and duckbills are functioning properly.The following tests were performed, and the affected sample passed the tests.It was found to function as intended and met all the product specifications.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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Safety valve leakage.
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Event Description
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The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was a safety valve leakage.As per the subsidiary, in the final stage of the surgery, blood was found to be leaking from the safety valve.As the amount of leakage was small, the valve was used as it was, and the surgery was successfully completed.No known consequence or health impact to patient.The product was not changed out.There was a less than 1 ml of blood loss.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 july 13,2023.Upon further investigation of the reported event, the following information is new and/or changed: b5 (updated describe event or problem); 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 and correction) ; 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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