Medtronic received information that prior to use of a fusion oxygenator, during priming a water leak was noted from around the cardioplegia cap.The cap was re-tightened, but it did not feel like it was closed tightly and it seemed to spin idle.The cap was removed, the tube was connected, it was fastened with a tie gun and clamped to complete the procedure.There was no impact to the patient associated with this event.The customer stated that the cap and port could not be seen to be deformed just by looking at them and that the package had not been found to be deformed.
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Device evaluation summary: visual inspection shows no outward signs of physical damage or abnormalities.Device appears to have been primed.The returned caps were reinstalled.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 were no leaks observed from either cap.Conclusion: complaint not confirmed for a leak from the cardioplegia port luer cap (red cap), resulting in a leak during prime.Medtronic was unable to replicate the occurrence.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 there were no patient/clinical safety issues reported.Trends for issues with this product are reviewed at quarterly quality meetings.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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.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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