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Model Number BB811 |
Device Problem
Increase in Pressure (1491)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/10/2021 |
Event Type
Injury
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Manufacturer Narrative
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Device evaluation summary: visual inspection shows no outward signs of physical damage or abnormalities.Unit appears to have been used.Pressure integrity testing shows no internal or external leaks when run at 3 lpm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.The device was sent to the blood lab for performance testing.Reason for return was not confirmed.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that during use of a custom tubing pack during a coronary-artery bypass graft (cabg) + dor procedure, the customer observed that about 2-3 minutes after the pump started, the pressure in front of the fusion oxygenator suddenly rose, and the temperature increased.The blood was warmed by setting the temperature of the cold / hot water tank to about 35 degrees to encourage the pressure to drop, but it did not drop.This was done as an intervention by an extracorporeal circulation engineer.Normally, the procedure is in the stage of cooling at room temperature, but the pressure of the artificial lung became high, so the customer tried to warm to about 35 degrees.The oxygenator was replaced and the procedure was completed without any problems.There was no patient impact associated with the event.
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Manufacturer Narrative
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Investigation conclusion: complaint not confirmed for the fusion oxygenator's high pressure.Analysis of the returned device was unable to replicate the reported incident.The returned oxygenator resulted in a blood side pressure drop of 182 mmhg at a flow rate of 7 l/min.This is used as an indicator for device performance from a restricted flow or high pressure drop perspective, and the results were as expected.The device history record was reviewed; devices are required to pass manufacturing inspections and specifications prior to release and no abnormalities were documented which would cause or contribute to the reported occurrence.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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