|
Model Number 511B |
Device Problem
Material Puncture/Hole (1504)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/31/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Medtronic received information that prior to use of an affinity nt oxygenator, it was reported that there was a damaged spot noticed during the priming.The oxygenator was replaced to complete the procedure.There was no patient involvement, so no adverse effect occurred.It was also reported that the reservoir was fine.However, it is suspected that the full circuit was not replaced possibly due to in sufficient time for priming all the components as the surgery was ongoing.There was no damage to the packaging and the condition of the other devices in the same box was good.
|
|
Manufacturer Narrative
|
Device evaluation summary: visual inspection showed that the oxygenator was returned with a section of the top cap broken off.The reason for return was confirmed.Conclusion: the reported event was confirmed.The gas cap component has features that enable connection of the oxygenator with the cardiotomy venous reservoir.This type of damage is typically associated with a significant physical shock probably during shipping and handling.The device history record for the reported serial number was reviewed and no anomalies or deviations in the manufacturing process were identified, which would cause or contribute to the reported event.Production information was reviewed, and the product had passed all in-process quality checks; manufacturing controls are in place for the inspection of each device to ensure that product meets specification prior to the release from the manufacturing facility.All associated risks are low, and no device related patient/clinical safety issues were reported.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.
|
|
Search Alerts/Recalls
|
|
|