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

Model Number 95215

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use, the customer reported an issue with the nt oxygenator.Perfusionist set up and primed the oxygenator with no issues.Cpb was initiated and noticed the oxygen levels were good.He checked the blender and oxygen connections and all were good.He then connected oxygen tank to the circuit in case the hospital source was defective.He turned the oxygen way up and got some improvement.After a few minutes, the oxygen levels were back down.He informed the surgeon that he was going to change out the oxygenator.Upon doing this when he removed the oxygenator from the cardiotomy/venous reservoir (cvr) and a huge piece of the gas cap broke off the oxygenator and remained connected to the cvr.The customer suspects there was a crack in the gas cap of the oxygenator and it was leaking and that is why the oxygen levels were low.When he removed it, the oxygenator broke along the crack.The product was replaced.There was no adverse effect to the patient.All of this occurred after the cross clamp was placed and cardioplegia was given.The perfusionist said it took about 6 to 7 mins to change out and re-initiate cpb.Anesthesia ventilated and the surgeon feels all is ok.The patient exhibited normal post op characteristics.No patient effects.Patient has been discharged.

Manufacturer Narrative

Conclusion: the customer did not return the device but supplied pictures that provide clear evidence of a damaged gas cap.This type of damage is typically associated with a physical shock encountered during shipping and/or handling; however, the specific cause is unknown.Cracks in the gas cap when small can be difficult to notice and might not effect performance of the device.Throughout the assembly process each device is visually inspected, manufacturing controls are in place to ensure that product meets specification prior to the release from the manufacturing facility.Within medtronic control, no damage reports were received through sterilization or distribution centers.The dhr for the device was reviewed and did not identify any anomalies or deviations in the manufacturing process which would cause or contribute to the reported event.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: 9787269
• MDR Text Key: 182297863
• Report Number: 2184009-2020-00013
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K191029
• 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: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2021
• Device Model Number: 95215
• Device Catalogue Number: 95215
• Device Lot Number: 13313981
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 110