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Model Number IBP4370 |
Device Problems
Coagulation in Device or Device Ingredient (1096); Biocompatibility (2886)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Local Reaction (2035); Vomiting (2144); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/27/2023 |
Event Type
Injury
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Manufacturer Narrative
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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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According to the reporter, 30 minutes after the start of rrt (renal replacement therapy), allergic symptoms were noted (significant decrease in blood pressure, significant change in white blood cell count, and platelet count), coagulation in the circuit or column, marked residual blood, etc.It was also stated that the patient had vomited.Qb (blood flow rate) was 150ml/min, qd (dialysis fluid flow rate) was 500ml/min, and qf (ultrafiltration rate) was 33.3 ml/min.No previous implementation conditions or changes were made at the start of the use of the product.The competitor's product was used before switching to the new one.There was no alarm activated.No visible damage or defects were found on the product.Nothing unusual was observed on the device prior to use.Hdf (hemodiafiltration) membrane replacement was the medical intervention; blood pressure increased, feelings of discomfort disappeared, and the treatment was completed.Heparin (initial (b)(4) units, continuous (b)(4) units) was the coagulant type and the medication given to the patient.No other intervention or treatment was required as a result of the event.There was no blood loss.A blood transfusion was not required.No lab or test was done due to the event.The patient had no medical history of allergic reactions during a dialysis treatment.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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