PERFUSION SYSTEMS DLP LEFT ATRIAL PRESSURE MONITORING CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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Model Number 50010 |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 04/09/2019 |
Event Type
Injury
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Manufacturer Narrative
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Medline industries, inc.Forwarded this complaint to medtronic on 17th may 2019.Medline's reference number for reporting is (b)(4): 1423395-2019-00017.The device will not be made available by the customer for medtronic's analysis.The investigation is ongoing.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that when the patient was being monitored in the facility's cardiac intensive care unit post-operatively and when a staff member repositioned the hub of the dlp left atrial pressure monitoring catheter placement set by peeling back the securement tape, the line fell apart.When this occurred, the catheter placement set was reportedly clamped on the exposed end, cleaned with cholraprep and covered with a tagaderm.The customer stated that the catheter placement set line was left in the patient and removed the next day by the cardiovascular operating room team.It is unknown how long the device had been in use when the break occurred.It is unknown how the device was removed from the patient.There was no serious injury noted and no follow-up care noted.No additional medical intervention was reported.The customer stated that the patient is stable, no issues related to this incident.
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Manufacturer Narrative
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Investigation conclusion; after investigation at medtronic, the issue of the broken pressure monitoring catheter is confirmed based on the photo provided.It is unknown what may have caused this issue, and the root cause of this occurrence cannot be determined without returned product.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.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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