MAUDE Adverse Event Report: PERFUSION SYSTEMS VACUUM RELIEF VALVE; APPARATUS, AUTOTRANSFUSION

Model Number 1140333-1

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Air Embolism (1697)

Event Date 07/08/2020

Event Type  Death  

Manufacturer Narrative

Visual analysis: upon receipt in our quality analysis lab, visual inspection showed no outward signs of any damage.The device had a test mark, which confirmed the vrv was tested prior to distribution.Device was cleaned using a 10% bleach solution.Performance analysis: functional testing of the returned device was performed at 0.5 l/min.The instructions for use provides an app roximation for first time use of negative and positive pressures to open the umbrella relief valves at 0.5 l/min blood flow are approximately -205 mmhg and 318 mmhg.Our results indicated the negative pressure umbrella opened at -166 mmhg and the positive pressure umbrella valve opened at 366 mmhg verifying the functionality for the valves for the returned device.The acceptable function of the umbrella valves also confirms the duck bill valve functioned as intended.The device appeared to operate as expected.There were no bubbles or any evidence of a "venturi effect".Conclusion: reason for return was not confirmed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use, about 10 minutes into the procedure, the customer reported the one way valve in the vent line was subject to a "venturi effect", resulting in air being pumped to the patient, filling the heart with air.See attached device image.The device was replaced with a non-medtronic one way valve.The patient died on (b)(6) 2020.Patient is alleged to have died as the result of air in the vent line.Perfusion records for the case are not available.No damage/anything atypical noted to the one way valve.

Manufacturer Narrative

Complaint is unconfirmed for valve introducing air into the patient.There was no observed damage to the device and performance testing indicated that the device functioned as intended.After analysis it was determined there was no product failure that occurred during the reported event.A review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Assessment against the medtronic risk management file indicates that the current risk zone does not exceed the risk zone predicted; therefore, no capa will be initiated at this time.This investigation was completed with the information that was provided, if additional information is received, this investigation will be reopened if deemed necessary.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.

Event Description

Medtronic received information that during use, about 10 minutes into the procedure, the customer reported the one way valve in the vent line was subject to a "venturi effect", resulting in air being pumped to the patient, filling the heart with air.The device was replaced with a non-medtronic one way valve.The patient died on (b)(6) 2020.Patient is alleged to have died as the result of air in the vent line.Perfusion records for the case are not available.No damage / anything atypical noted to the one way valve.

• Brand Name: VACUUM RELIEF VALVE
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 10378562
• MDR Text Key: 202010930
• Report Number: 2184009-2020-00040
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• PMA/PMN Number: K953564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

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 Expiration Date: 05/31/2021
• Device Model Number: 1140333-1
• Device Catalogue Number: 1140333-1
• Device Lot Number: 219239756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 77