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Model Number BB811 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problems
Air Embolism (1697); Anemia (1706); Hemorrhage/Bleeding (1888)
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Event Date 10/03/2022 |
Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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Medtronic received information that during use of a fusion oxygenator, it was reported that there was leakage of blood from the oxygenator during the entire procedure.The device was used to complete the procedure.It was noted that the oxygenator appeared to be cracked.The amount of blood loss was 150 ml. there was no additional patient impact associated with this event.Medtronic received additional information that the patient had severe blood loss, decreased hemoglobin, air intake, group water mixture heat with blood.
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Manufacturer Narrative
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Correction a3: event date updated medtronic received additional information that it is possible that the patient blood came in contact with the water of the intercooler by the fissure.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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Manufacturer Narrative
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Complaint confirmed for the fusion oxygenator's leak from the bottom of the device.The device did not return for analysis, however, the issue was verified via the customer-provided video/photos, which appears to show a leak from the bottom of the device.The customer-provided photos appear to show a "snorkel leak", in which a small fiber captured in the potting material can create a straw like leak.During winding of the fiber bundle if either end of the fiber gets caught in the urethane potting material, a snorkel fiber can occur.This fiber creates a pathway which can result in a leak to the atmosphere.Fiber bundle leaks occasionally occur in oxygenators made with microporous membrane due to the variability in the fiber.Although these leaks do occur, the fusion oxygenator is 100% leak tested during production, and devices that exhibit leaks are discarded prior to distribution.It is possible pressure from adjacent fiber wraps lead to the acceptable results during leak testing, but the fiber relaxed during further processing, resulting in the leak.B.5 updated - medtronic received additional information that no transfusion was required.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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