COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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Model Number 8813793009 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 09/01/2021 |
Event Type
Death
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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, continuous renal replacement therapy (crrt) was in progress with femoral vein access at 15:00 on (b)(6) 2021.It was reported that they found a separate result in the crrt dialysis process and an artificial respirator and extracorporeal membrane oxygenation (ecmo) was used.On the next day, (b)(6) 2021 at 19:40 three nurses conducted to arrange the patient¿s position.The crrt return line pressure alarm rang and when they checked the line it was found that blood was leaking near the 5cm catheter connected to the return line.Immediately, the patient was clamped with a clamp on the bed and the kit's blood loss was about 152cc.They stopped crrt operation and dialysis was re-implemented after re-intubation tube and re-priming.It was stated on the report that the patient died.
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Manufacturer Narrative
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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 there was a leak or hole on the extension tube.The reported issue 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.A secondary review of the device history records found no potentially contributing factors.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.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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