###a supplemental report is being submitted for device analysis.Product event summary: the controller ((b)(6)) was not returned for evaluation.Log file analysis revealed eleven (11) controller power up events with associated pump start events were logged between (b)(6) 2021 and (b)(6) 2021.The controller can only store a maximum of 30 days of data.After reaching the limit, the controller initiates a first-in first-out method whereby the oldest data point is deleted to allow the newest data point to be recorded.As a result, data logs covering the power up events were not available.The controller was without power for an average of 15 seconds per loss of power.As a result, the reported losses of power event could not be confirmed.The reported no sound event could not be confirmed.Additionally, log file analysis revealed a slight increase in power consumption and estimated flows on (b)(6) 2022; however, no alarms have been logged for the past 14 days leading up to (b)(6) 2022.Information provided by the site indicated that the patient did not experience any signs or symptoms, but had a subtherapeutic international normalized ratio (inr).The patient was admitted for heparin bridging.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of the reported no sound event may be attributed to, but not limited to, an obstruction of the gore-tex membrane and/or a faulty speaker.A possible root cause of the losses of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Capa (b)(4) is investigating controller losses of power.Based on the risk documentation, possible causes of the observed high power event may be attributed to multiple factors including but not limited to external factors such as thrombus formation/ingestion, inappropriate pump rotational speed, and/or patient related factors.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.### 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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