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

Model Number 95215

Device Problem Air Leak (1008)

Patient Problem Ischemia (1942)

Event Date 03/24/2016

Event Type  Injury  

Manufacturer Narrative

Medtronic is unable to determine a relationship between the product and the patient outcome at this time, as no product has been returned and is not expected to return.Additional information regarding the event is being pursued, but no responses have been received to date.

Event Description

Medtronic received information indicating that during a case, the customer reported air bubbles entered the oxygenator, exited through the tubing, and traveled through the circuit to the patient.The oxygenator was replaced with another to complete the case.The customer reported this issue resulted in ischemia to the patient's brain.

Manufacturer Narrative

Medtronic is unable to determine a relationship between the product and the patient outcome at this time, as the product was indicated as discarded by the user facility.Without sufficient details or a returned device, the event cannot be verified and root cause cannot be determined.Medtronic will continue to monitor for trends and additional occurrences.

Event Description

Medtronic received information indicating that after releasing the clamp on the aorta during a procedure, the customer noted air bubbles in the oxygenator that exited through the tubing, and traveled through the circuit to the patient.The oxygenator was replaced with another to complete the case.The customer reported the patient had difficulty awakening after the procedure suggesting ischemia to the patient's brain.The patient's current status was reported as stable and no additional adverse effects were reported.

Manufacturer Narrative

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

Manufacturer Narrative

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
• 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: 5592172
• MDR Text Key: 43154903
• Report Number: 2184009-2016-00008
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K143073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 95215
• Device Catalogue Number: 95215
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening
• Patient Age: 52 YR
• Patient Weight: 55