MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS FUSION HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BB811

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Thrombus (2101)

Event Date 05/19/2016

Event Type  Injury  

Manufacturer Narrative

Upon receipt at medtronic's quality laboratory, visual inspection showed evidence of clotting within the device.Performance testing was performed.During the pressure integrity test the blood side pressure drop was comparable to historical averages.

Event Description

Medtronic received information that approximately 30 minutes into extracorporeal circulation, the customer noted a change in flow (flow volume was 4.3 liters and a pressure drop of approximately 100 mmhg) and thrombus formation within this fusion oxygenator.Thrombus formation was not observed in any other portion of the circuit.The customer elected to replace the device with another manufacturer's product.After the device was replaced, the customer observed thrombus formation near the left common carotid artery (cca), and a thrombectomy was performed.Suction was administered near the site and a large thrombus was visible inside of the cell saver; thrombus was also observed at the aortic arch, but does not appear to have been removed.The customer indicated it is unknown whether the thrombus originated in the oxygenator or the patient.A magnetic resonance imaging (mri) of the head was performed and did not show significant cerebral infarction.

Manufacturer Narrative

Upon completion of the investigation, results suggested the anticoagulation was likely inadequate and the high pressure experience was patient or clinically related.Performance testing for high pressure drop was conducted and the results indicated the device functioned as intended.The examination of the oxygenator showed the fiber bundle was stained, suggesting some type of protein build up, cryoprecipitate or cryofibrinogen that caused the initial flow restriction and the development of the thrombus.Medtronic will continue to monitor for similar occurrences and trends.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: FUSION HOLLOW FIBER OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland drive; brooklyn park MN 55428
• Manufacturer (Section G): MEDTRONIC PERFUSION SYSTEMS; 7611 northland drive; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5727893
• MDR Text Key: 47487768
• Report Number: 2184009-2016-00014
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2017
• Device Model Number: BB811
• Device Catalogue Number: BB811
• Device Lot Number: 13143820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 06/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention