Medtronic received information that at an unspecified time, this act plus instrument blood check/screening/inspection was not working.Use of the instrument was unspecified.There was no patient impact reported with this event.Additional information received that there was no error code,the customer noticed that the results were were inconsistent (very low act times ).The issue was due to an excessive presence of blood on the optical sensors (the users had not performed the cleaning procedure).Another device was usedfor management of the heparin administration.
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Correction section h4 device manufacturing date: this field has been updated.Conclusion: after investigation the complaint is confirmed for the act plus instrument¿s reported blood check/screening/inspection not working.The issue was verified during service.The issue was due to an excessive presence of blood on the optical sensors (the users had not performed the cleaning procedure).The issue was resolved by cleaning the instrument and replacing the board sensor assy flag act plusbd.Preventive maintenance was performed per specifications.No patient/clinical safety issues were reported.Trends for issues with this product are reviewed at quarterly quality meetings.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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