MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND INVOS; OXIMETER, TISSUE SATURATION

Model Number 5100C

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Title: elevated venous to arterial carbon dioxide gap and anion gap are associated with poor outcome in cardiogenic shock requiring extraco rporeal membrane oxygenation support source: asaio journal 2021; 67:263¿269 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.

Event Description

According to literature source of study performed, a retrospective cohort study was conducted on patients with an admission diagnosis of cardiogenic shock who subsequently required venoarterial extracorporeal membrane oxygenation (va-ecmo) support at a tertiary intensive care unit (icu) between april 2009 and december 2018.Venous blood samples were taken from the ecmo circuit pre-oxygenator, arterial samples from the patient¿s right radial arterial line (within 10 minutes of each other).All measurements in this study were conducted 24¿36 hours after initiating va-ecmo support and in the final 24 hours of va-ecmo support before successful weaning or a decision to withdraw ecmo support.Between april 2009 and december 2018, a total of 207 patients received vv or va-ecmo.One hundred seventy-six patients did not meet the inclusion criteria.Thirty one patients with cardiogenic shock were included for review, of which 16 (52%) survived, while 15 (48%) died, primarily due to multi-organ failure.One patient in the survivor group died 4 days post-ecmo.This patient was placed on ecmo for cardiogenic shock (decompensated dilated cardiomyopathy) and after 8 days of support was successfully weaned from ecmo.However, the patient developed sepsis resulting in irreversible septic and distributive shock, passing day 3 post-ecmo.One further patient died 14 days after ecmo removal.This patient developed a femoral artery dissection post-removal leading to gangrenous left leg requiring above-knee amputation.Sepsis (staph epidermis) developed resulting in multi-organ failure and death.These two deaths (post-ecmo) resulted in an overall 30-day mortality rate of 55% (17/31).

Manufacturer Narrative

This event has been reassessed and the reportability has been determined to be a not a complaint.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.

• Brand Name: INVOS
• Type of Device: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• Manufacturer (Section G): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17162272
• MDR Text Key: 317499969
• Report Number: 8020893-2023-00381
• Device Sequence Number: 1
• Product Code: MUD
• UDI-Device Identifier: 10884521211179
• UDI-Public: 10884521211179
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5100C
• Device Catalogue Number: 5100C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1