Model Number 3CX*NX19RW |
Device Problem
Leak/Splash (1354)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/27/2020 |
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 (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, the clinician noticed a leak at the inlet while priming.*no patient involvement *product was changed out *procedure 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 december 18, 2020. upon further investigation of the reported event, the following information is new and/or changed: h6 (adverse event problem 527, 2645, 4582, 67, 11).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: the affected sample was inspected upon receipt to note slight damage to the venous inlet of the reservoir and the blood inlet of the oxygenator.The affected sample was setup to circulate water and observe for leakage.A representative retention sample was inspected with no visual damage.It then was setup to circulate water for leakage.No leakage were observed on the actual and retention samples.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 18, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 527, 4582).Component code: 527 - valve.Health effect clinical code: 4582 - no clinical signs, symptoms or conditions.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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