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Model Number 8888135191 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2023 |
Event Type
malfunction
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Event Description
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According to the reporter, the patient underwent hemodialysis treatment on the day of the event.When the nurse inspected the patient at 08:50, it was found that the a19 machine had an alarm that indicated low venous pressure and insufficient blood flow.The nurse immediately reported it to the doctor and head nurse to check the pipeline.After the pipeline was checked, it was found that the venous end or the connection between the venous silicone extension tube and luer adapter of the catheter was damaged (had small holes) and had bleeding (blood or liquid leakage), which made normal dialysis impossible.There was nothing unusual observed on the device prior to use.There were no other products utilized with the device.There was no excessive force used on the device.The clamp was moved periodically.The cleaning agent used on the device was iodophor cotton balls.The insertion site was treated with iodophor cotton balls prior to product placement.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.There was no issue with the machine that could contribute to the event.To resolve the issue, the patient was immediately removed from the machine and needed to be re-tubed.The product was replaced on the same day of the event.The treatment was completed after resolving the issue.There was a very small amount of blood loss, and a blood transfusion was not required due to the event.There was no medical intervention/treatment provided to the patient due to the event.There was no reported patient 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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Manufacturer Narrative
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Additional information: b7, g3 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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