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Model Number CB811 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Medtronic received information that prior to use of a fusion oxygenator, it was reported that there was a leakage at the temperature port during priming.The device was replaced.There was no patient involvement, so no adverse effect occurred.
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Manufacturer Narrative
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Device evaluation summary: visual inspection shows evidence of damage/crack in the tma port.Unit appears to have been primed.Pressure integrity testing was performed at 3 l/pm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.During the pressure integrity testing there was a leak observed from the tma port.Reason for return was confirmed.D1.(brand name) and d4.(model number), (catalogue number), (serial number) and (lot number): these fields have all been updated.E.Initial reporter: (first name), (last name) and (phone number): these fields were updated.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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