Investigation - complaint confirmed for leak.Medtronic received information that during use of an affinity nt oxygenator, the oxygenator leaked when the patient¿s valve replacement was changed to cardiopulmonary bypass.Plasma protein leaked from the oxygenator.Blood was lost due to the leak and the specific amount of leaking fluid was unknown by the user.A blood transfusion was required.The device was used to complete the procedure.There was no adverse patient effect reported.Device was not returned for analysis so a cause cannot be determined but pictures were provided that confirm the report.The affinity nt oxygenator fiber/plasma leaks are an extremely low occurring phenomena with devices made with microporous membrane.The product is designed to maximize the performance and robustness of the oxygenator and medtronic uses extremely sophisticated techniques for identifying leaks in the production process.The dhr for the reported serial number of the device was reviewed and did not identify any anomalies or deviations in the manufacturing process which would cause or contribute to the reported event.This investigation was completed with the information that was provided, if additional information is received, this investigation will be reopened if deemed necessary.Trends for issues with this product are reviewed at quarterly quality meetings.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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