PERFUSION SYSTEMS AFFINITY PIXIE PEDIATRIC HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS
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Model Number BBP211 |
Device Problem
Gas Output Problem (1266)
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Patient Problem
Low Oxygen Saturation (2477)
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Event Date 07/29/2021 |
Event Type
Injury
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Manufacturer Narrative
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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 pixie oxygenator, the customer reported that cardiopulmonary bypass was instituted using direct ascending aortic cannulation with 16fr and cannulation of the svc 16 fr and ivc 18 fr.Fifteen minutes after commencement of cpb, a rise in the partial pressure of carbon dioxide was noted pco2(52) with 2l sweep gas, po2(37.4.), so2(61.4%).Suspicion of membrane oxygenator failure was raised. the customer then elected to replace the pixie oxygenator.To prepare for this, the patient was cooled to 25°c as measured on the nasopharyngeal temperature probe.Intravenous dexamethasone and was administered by the anesthetist and the ice pack was applied to the patient¿s head.Once these maneuvers were performed, cpb was terminated and the membrane oxygenator replaced by two staff perfusionist following strict departmental protocol.Following replacement of the membrane oxygenator, the pco2 returned to 40.1 mmhg and po2 (439mmhg), so2 (99.9%) and remained within the acceptable range for the rest of the procedure.The patient was safely weaned off from the cpb, still on ventilator and on inotropic support, noradrenaline 0.8ml/hr.And dobutamine 0.5ml/hr. the customer can¿t assess the gcs level as the patient received muscle relaxant once shifted to icu.The patient spent an additional 3 days in icu and was on ventilator for more than one day as the gcs was 10.They gradually retained 15/15 gcs.On the 3rd post operative day, the patient was discharged from the hospital.
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Manufacturer Narrative
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Investigation conclusion: complaint not confirmed for the pixie oxygenator's poor gas exchange.The issue could not be verified as no device returned for analysis.Review of this unit¿s device history record found no abnormalities or ncmrs initiated during manufacturing that would cause or contribute to the reported event.This unit passed all required testing and inspections during manufacturing.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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