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Model Number 8888135191 |
Device Problem
Pumping Problem (3016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/23/2021 |
Event Type
malfunction
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Event Description
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According to the reporter, when crrt (continuous renal replacement therapy) was performed on the patient on (b)(6) 2021 at 10:30 in the morning, at the place where the arteriovenous intubation catheters were connected, during the process of blood drainage, oozing blood was found at the venous end of luer adapter of the arteriovenous catheter.It was stated that there was crack noted where the leak was observed.Flushing was done prior to use and it was normal.There was no blood loss and blood transfusion was not required.Iodophor was the cleaning agent typically utilized to clean the adapters.Cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.Hand was utilized to tighten the adapters.There was no other products being utilized with the device.There was no intervention/treatment required as a result of the leakage.There was nothing unusual observed on the device prior to use.Blood gave back immediately, reported to the head nurse and doctor on duty, and replaced with the femoral venous catheter.It was stated that the procedure was completed.Everything was normal after replacing the catheter and there was no patient injury.
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Manufacturer Narrative
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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: b5, g1 (mfr contact first name, last name, email, phone number), g3, h3.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, when crrt (continuous renal replacement therapy) was performed on the patient on (b)(6) 2021 at 10:30 in the morning, at the place where the arteriovenous intubation catheters were connected.During the process of blood drainage, oozing blood was found at the junction venous end of luer adapter and extension tube of the arteriovenous catheter.It was also stated that there was a crack noted where the leak was observed.Flushing was done prior to use and it was normal.There was no blood loss and blood transfusion was not required.Iodophor was the cleaning agent typically utilized to clean the adapters.Cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.Hand was utilized to tighten the adapters.There were no other products being utilized with the device.There was no intervention/treatment required as a result of the leakage.There was nothing unusual observed on the device prior to use.Blood gave back immediately, reported to the head nurse and doctor on duty, and replaced with the femoral venous catheter.It was stated that the procedure was completed.Everything was normal after replacing the catheter and there was no patient injury.
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Manufacturer Narrative
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Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the luer adapter was found to be cracked, leaking, or broken as a result of a manufacturing issue.It was reported that there was a leak on the extension tube.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: clamping repeatedly on the same spot could weaken the tubing and clamping near the adapter and hub should be avoided.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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