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

Model Number CB96345-023

Device Problem Mechanical Problem (1384)

Patient Problems Ischemia (1942); Vascular Dissection (3160)

Event Date 11/01/2010

Event Type  Injury  

Manufacturer Narrative

The investigation for this device is ongoing, the results will be supplied in supplemental report.Literature reference - 10.1097/imi.0b013e3182029a83.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding thromboembolic events in patients on extracorporeal membrane oxygenation without anticoagulation.All data were collected retrospectively from a single center between 2000 to 2008.The study population included 32 patients predominantly male, median age 52.5 years.Medtronic devices used were bio-medicus cannula,bio-medicus centrifugal pump and custom pack, serial numbers not provided.Among all patients, adverse events included: limb ischemia requiring intervention, acute renal failure, deep vein thrombosis and intracardiac clots.Based on the available information, these adverse events were not attributed to medtronic product.Based on the available information a direct correlation could not be made between the observed adverse events and medtronic product.Among all patients, device malfunctions included: mechanical complication of cannulation causing dissection of the femoral artery in one patient leading to ischemia.Based on the available information, these malfunctions may have been attributed to medtronic product.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Continued from block h6: fdc 24 added: information provided by the literature article indicated that the device was used for ecmo; this device is indicated for use for up to six hours or less.Literature details; thromboembolic events in patients on extracorporeal membrane oxygenation without anticoagulation innovations 2010 author; yoan lamarche et al.Literature reference - 10.1097/imi.0b013e3182029a83 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: CARMEDA BIOMEDICUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 10547629
• MDR Text Key: 212297221
• Report Number: 2184009-2020-00050
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K924642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CB96345-023
• Device Catalogue Number: CB96345-023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR