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Model Number 8888135191 |
Device Problems
Device Contamination with Chemical or Other Material (2944); Infusion or Flow Problem (2964)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/23/2019 |
Event Type
malfunction
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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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Event Description
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According to the reporter, during use, it was reported that as hemofiltration was performed, there was poor blood flow.It was stated that foreign bodies were found in the tube on ultrasound.It was also reported that the catheter was not repaired, there was no leak, iodophor was the cleaning agent used on the device, tego was not used, and there was no luer adapter issue.The catheter was replaced.There was no patient injury.
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Manufacturer Narrative
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Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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, during use, it was reported that as hemofiltration was performed, there was poor blood flow.It was stated that foreign bodies was found in the tube on ultrasound, the device was impossible to be flushed with a syringe, after extraction a sponge like substance was flushed out.It was also reported that the catheter was not repaired, there was no leak, iodophor was the cleaning agent used on the device, tego was not used, and there was no luer adapter issue.The catheter was replaced.There was no patient injury.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted the device appeared intact pmv performed functional testing; the blue and red lumen had a test guide wire inserted , no occlusion noted.The distal end of the cannula was clamped and a water bath test was performed on the both sides side, no air bubbles detected.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.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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