Conclusion: based on the available information medtronic cannot confirm or deny the reported allegation against the pixie oxygenation system (bbp241).This event was reported after execution of fca cvg-21-23 and is associated with a corrective and preventive action.A clinical review was performed with the office of medical affairs, postmarket quality engineering, and microbiology.No device returned to medtronic for analysis.Review of this unit's device history record found no abnormalities or non-conforming material reports initiated during manufacturing that would cause or contribute to the reported event.This unit passed all required testing and visual inspections during manufacturing.Additional information including event details, patient details, perfusion records, and official cause(s) of the reported adverse events was requested but was not available.The root cause is undetermined.Trends for issues with this product are reviewed.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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Upon execution of fca cvg-21-q3-23 medtronic received information that post use of a pixie oxygenator and cardiotomy venous reservoir, the patient had an infection.The patient's current status is unknown.The below additional information was requested, but is unavailable: - the date of the event - device details - official cause of the reported adverse event.
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