MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY HFO W/TRILLIUM 511T; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 95215

Device Problems Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2019

Event Type  malfunction  

Manufacturer Narrative

Device return has been requested.Device will be analyzed on receipt at medtronic's analysis lab.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use, the customer reported the nt oxygenator was unable to oxygenate.The clinician noticed poor to no gas transfer upon start of bypass.Bypass was terminated and device was changed out.When the oxygenator was disconnected from the cvr, the clinician noticed the gas cap was cracked and dislodged.There was no adverse effect to the patient.

Manufacturer Narrative

Visual analysis: visual inspection shows a section of the gas cap has broken off.The device was cleaned using a renalin solution.Performance analysis: pressure integrity testing shows no internal or external leaks when run at 3 lpm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.Based on test results, from the blood lab of other returned devices with similar damage shows this is a representative failure mechanism of poor gas transfer.Conclusion: reason for return was confirmed with the broken gas cap.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: AFFINITY HFO W/TRILLIUM 511T
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 9472547
• MDR Text Key: 196213107
• Report Number: 2184009-2019-00082
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K162896
• 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: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2020
• Device Model Number: 95215
• Device Catalogue Number: 95215
• Device Lot Number: 13304409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 12/17/2019
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention