MAUDE Adverse Event Report: PERFUSION SYSTEMS PEDIATRIC BIOMEDICUS FEMORAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96820-108

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/16/2022

Event Type  Injury  

Event Description

Medtronic received information via literature regarding the outcome of extracorporeal membrane oxygenation (ecmo) for severe adenovirus (adv) pneumonia with refractory hypoxic respiratory failure (rhrf) in paediatric patients.All data were collected from a single center between 2017 and 2020.The study population included 18 patients (predominantly female; mean age 19 months), some of which were treated with medtronic bio-medicus cannulae (serial numbers not provided).Other manufacturers' products were also used in the study.Among all patients, 5 deaths occurred.Based on the available information, none of the deaths were attributed to medtronic product.Among all patients, adverse events included cannulation site bleeding.Based on the available information, these adverse events may have been attributed to medtronic product.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Literature details: title: extracorporeal membrane oxygenation for pediatric refractory hypoxic respiratory failure caused by adenovirus in shanghai: a case series authors: yun cui, jingyi shi, yiping zhou, jiaying dou, xi xiong, ting sun, yijun shan, tingting xu, ye lu and yucai zhang journal: bmc pediatrics (2022) 22:138 doi: https://doi.Org/10.1186/s12887-022-03197-2.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.

Manufacturer Narrative

Conclusion: medtronic cannot confirm or deny the complaint of cannulation site bleeding during extracorporeal membrane oxygenation (ecmo) for severe adenovirus (adv) pneumonia with refractory hypoxic respiratory failure (rhrf) as no product has been returned to date.A root cause of this occurrence cannot be determined without returned product.A clinical review was completed with medtronic medical safety and review concluded none of the adverse events reported directly contributed to patient mortality.Additionally, all patients in this study were critically ill with severe adv pneumonia and patient mortality may have been a result of these underlying conditions as severe adv pneumonia has a high mortality rate and is associated with a higher risk of death in infants and young children.None of the medtronic devices mentioned in this article are available for evaluation.During the time period reported in the literature article, the nextgen bio-medicus one-piece femoral arterial / jugular venous cannula were only ¿intended for use up to 6 hours¿ and use beyond 6 hours would be considered off-label.Cannulation site bleeding is not a new or unexpected adverse event associated with the use of these cannula devices and is predicted as a known or foreseeable risk within risk management documentation.The device history record could not be reviewed as no lot number was provided.Complaints received from (b)(6) 2017 through (b)(6) 2023 for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.Medtronic will continue to monitor for future occurrences and trends.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: PEDIATRIC BIOMEDICUS FEMORAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16037080
• MDR Text Key: 306060179
• Report Number: 2184009-2022-00460
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K143083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 96820-108
• Device Catalogue Number: 96820-108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19 MO
• Patient Sex: Male