MAUDE Adverse Event Report: PERFUSION SYSTEMS OXY/CVR COMBO BB841 FUSION W/BALANCE 26L; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BB841

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infarction, Cerebral (1771); Disability (2371)

Event Date 06/30/2017

Event Type  Injury  

Manufacturer Narrative

The product has not returned to medtronic for analysis.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Medtronic's investigation is in progress.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.

Event Description

Medtronic received information that at the end of a case, the customer observed thrombus formation inside of the cardiotomy/venous reservoir.During decannulation of the arterial cannula, thrombus was also observed on the tip of the cannula.Post operatively, it was reported the customer had a cerebral vascular infarct (cvi).Damage to the frontal lobe of the brain was confirmed via magnetic resonance imaging.As a result of the cvi, the patient can not speak; the results are suspected to be permanent.

Manufacturer Narrative

The product has not returned to medtronic for analysis.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Medtronic's investigation is in progress.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that at the end of a case, the customer observed thrombus formation inside of the cardiotomy/venous reservoir.During decannulation of the arterial cannula, thrombus was also observed on the tip of the cannula.Post operatively, it was reported the customer had a cerebral vascular infarct (cvi).Damage to the frontal lobe of the brain was confirmed via magnetic resonance imaging.As a result of the cvi, the patient can not speak; the results are suspected to be permanent.

Manufacturer Narrative

Review of photographs and video provided by the customer showed evidence of clotting/fibrin within the device during and after use.Upon receipt at medtronic's quality laboratory, visual inspection showed evidence of clotting and fibrin within the returned cardiotomy/venous reservoir (c/vr).The device was cleaned.Additional inspection did not show signs of physical damage or abnormalities.Review of the manufacturing data revealed the c/vr passed all manufacturing criteria prior to distribution; no manufacturing defects were found that would cause or contribute to the reported observation.Medtronic was unable to determine the root cause of the formation of clotting and thrombus observed during the procedure.Review of pump records from other cases found insufficient anticoagulation during the case to be the cause of clot formation within the cardiopulmonary bypass circuit.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that at the end of a case, the customer observed thrombus formation inside of the cardiotomy/venous reservoir.During decannulation of the arterial cannula, thrombus was also observed on the tip of the cannula.Post operatively, it was reported the patient had a cerebral vascular infarct (cvi).Damage to the frontal lobe of the brain was confirmed via magnetic resonance imaging.As a result of the cvi, the patient can not speak; the results are suspected to be permanent.

• Brand Name: OXY/CVR COMBO BB841 FUSION W/BALANCE 26L
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6731985
• MDR Text Key: 80671799
• Report Number: 2184009-2017-00027
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: K132972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 10/01/2018
• Device Model Number: BB841
• Device Catalogue Number: BB841
• Device Lot Number: 13189038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 74 YR