MAUDE Adverse Event Report: PERFUSION SYSTEMS CARPENTIER BI-CAVAL FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 58729

Device Problem Device Handling Problem (3265)

Patient Problems Air Embolism (1697); Brain Injury (2219)

Event Date 05/18/2000

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing for this literature event.Literature web address: 10.1016/s0003-4975(00)02198-6.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a case where a (b)(6) female patient was referred for elective repair of a secundum-type atrial septal defect.A minimal access surgical approach was planned using a right inframammary incision.Cardiopulmonary bypass was instituted using access through a right groin incision.A dlp carpentier two stage venous cannula was placed through the right femoral vein and positioned in the right atrium and superior vena cava.A dlp 60000 pressure monitor was used to measure venous line pressure, with the alarm set to trigger at negative 100 mm hg.After assembly of the circuit, cannulation and adequate heparinization, the suction lines were activated 2 to 3 minutes before the anticipated institution of cardiopulmonary bypass.The clamp on the venous line was removed and immediately deprimed retrograde toward the patient occurred.The line was immediately clamped.A quick examination of the circuit confirmed that the y line of the vacuum regulating device was open to the atmosphere.Air was noted high in the venous cannula and the confirmation of positive pressurization of venous reservoir was confirmed when a luer lock cap was removed resulting in an audible positive pressure release.It then became evident that the venous line had deprimed toward the patient.An immediate examination of the heart by transesophageal echocardiography revealed air in the right atrium, left atrium, and left ventricle.The positively pressurized venous line caused an air embolus into the right atrium with enough positive pressure that it superceded the pressure of the left to right shunt across the atrial septal defect resulting in a paradoxic embolus to left side of the heart.The needle valve assembly was expeditiously removed and replaced with a y tubing vented to the atmosphere.It was decided that minimal amounts of air had crossed the septal defect to the left side of the heart and that surgical correction should proceed as planned.The defect was repaired with an aortic cross-clamp time of 38 minutes.The patient was extubated in the operating room; however, immediate neurologic examination revealed a left hemiparesis and mental obtundation and a left visual field of homonymous hemianopsia.The patient was immediately taken to a hyperbaric oxygen chamber for decompression therapy.Over a period of 5 hours at a pressure of 3 atm the patient had immediate recovery of all neurologic function including the left hemiparesis and homonymous hemianopsia.Diffusion-weighted magnetic resonance imaging performed immediately on completion of decompression as well as on the fourth postoperative day were normal.The patient was discharged on the fourth postoperative day with a normal clinical neurologic examination.It was stated that a sequence of events contributed to the air embolism.A sealed venous reservoir without a positive pressure release valve was selected.The pressure alarm of the pressure monitor was set to trigger a negative ¿over limit¿ pressure rather than a small positive pressure.Inspection of the needle valve assembly revealed that the valve had been tightened down to a very restrictive lumen.Contributing to the problem was the placement of the needle valve between the reservoir and the y rather than between the y and the vacuum source leading a non-vented reservoir once the suctions were activated.This led to rapid positive pressurization of the venous reservoir.

Manufacturer Narrative

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: CARPENTIER BI-CAVAL FEMORAL VENOUS 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: 10289079
• MDR Text Key: 202916113
• Report Number: 2184009-2020-00033
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K140192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

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: 58729
• Device Catalogue Number: 58729
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR