PERFUSION SYSTEMS AFFINITY PIXIE PEDIATRIC HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS
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Model Number BBP211 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 04/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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Lot: there are two possible lot numbers for the device, 13298485 and 13305117.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 prior to use, the customer reported a leak from the pixie oxygenator during the purging of the extracorporeal circulation system with blood.The estimated volume of blood loss was 50 milliliters.A transfusion of red blood cells to the patient was required.The oxygenator was replaced to complete the case.There was no adverse effect to the patient associated with the event.No deterioration or damage to the packaging was observed.
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Manufacturer Narrative
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Visual inspection shows no outward signs of physical damage or abnormalities.Performance analysis: pressure integrity testing was performed at 1 lpm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.During the pressure integrity testing there were no leaks observed from the device.Reason for return was visually confirmed; however, it was not replicated during pressure integrity testing.Root cause is undetermined.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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Additional information received reported that it was necessary to add 50 ml of red blood cells to compensate for the losses due to the change of the oxygenator.Continued from d4: there are two possible expiration dates for the device: lot: 13298485 use by: 2021 ¿ 04 ¿ 30 lot: 13305117 use by: 2021 ¿ 06 ¿ 30.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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