PERFUSION SYSTEMS EOPA ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
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Model Number 77424 |
Device Problems
Fluid/Blood Leak (1250); Misassembled During Installation (4049)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 01/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Note on b3: date of event is approximate.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 an eopa arterial cannula, it was reported that during cannulation of the ascending aorta for a cardiopulmonary bypass case, the customer described that the white internal obturator did not fit the device as usual.The customer described that the blood pressure in the aorta was pushing out the obturator and the device body filled with blood more rapidly than usual.There was no resistance in withdrawing the obturator compared to the customer's usual experience and there was some leakage of blood from the red cap/ white obturator junction.The cannula was not heated or cooled prior to use.The patient blood loss was less than 20ml, and was scavenged by the heart lung machine and returned to the patient.A transfusion was not required as a result of this leak.The device was used to complete the procedure, as it was already in the aorta.There were no patient issues and the remainder of the operation continued without an event.There was no adverse patient effect associated with this event.
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Search Alerts/Recalls
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