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Model Number 8888145040 |
Device Problems
Break (1069); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/11/2023 |
Event Type
malfunction
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Event Description
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According to the reporter, upon arterial aspiration after being in dialysis for several minutes, a 30 cm (centimeter) strip of air was seen in the piping of the circuit.After noticing it, dialysis was interrupted.No air went to the patient.The patient was disconnected.After removal, the catheter was sent to the hospital tech department in two pieces.These were both cleared of blood debris (blood rests) via oxygenated water and flushed with water, and afterwards they were disinfected with chlorhexidine gluconas 2% (70% ethanolum) as cleaning agents used on the device.The end of the catheter was clamped off and connected via the venous and arterial lumen to a syringe filled with 0.9% nacl (sodium chloride).Both syringed through, with nothing to be seen.Afterwards, aspiration was performed, and nothing was seen there either.They performed the procedure again with the catheter submerged in water.Thereafter, both lumens were perfused with air, and air bubbles were seen at the level of the arterial connector.It was approximately at the wire (thread) section.It was also stated that air had leaked through a tiny hole that was not visible to the eye in the arterial lumen of the catheter.It was also mentioned that the location of the leak was the exit site.The circuit was fully primed and without air or air bubbles.The machine used was a competitor's product.The bloodline used was a competitor's product.It was also mentioned that during the connection procedure, no air bubbles were found in the arterial and venous lumens.The product was replaced with the same brand, different product id (identifier) and different lot.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: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the luer adapter was leaking, cracked or broken, and there was a leak or hole on the extension tube.The reported issues could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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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