MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY NT BALANCE; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 511B

Device Problems Fracture (1260); Device Difficult to Maintain (3134)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  Injury  

Manufacturer Narrative

Medtronic investigation: reported event was not confirmed.The device was not returned or available for analysis so the event cannot be confirmed.As the device was not returned and no valid serial number was provided, a dhr review was not possible.Lot number was provided and there are no known anomalies or deviations in this lot which would cause or contribute to the reported incident.Based on the information provided the cause cannot be verified but the most likely cause was related to damage to the gas cap preventing gas transfer due to gas side leak.This type of damage is typically associated with a physical shock encountered during shipping and/or handling.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.This investigation was completed with the information that was provided, if additional information is received, the investigation will be reopened if deemed necessary.Trends for issues with this product are reviewed at quarterly quality meetings.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of a fusion oxygenator, cardiopulmonary bypass (cpb) was initiated with no problems but after a few minutes, perfusion noticed a decrease in venous o2 saturation.This continued over the next minute or so.Perfusion checked the air/oxygen blender and then connected an oxygen tank to the oxygenator.Nothing was working so they decided to change out the oxygenator.This only took 3 to 4 minutes and cpb was re-initiated.However, during the change-out, when the oxygenator was removed from the cardiotomy venous reservoir (cvr), a portion of the oxygen cap on the top of the oxygenator completely broke off.A pie-shaped piece of the cap broke off and stayed connected to the cvr.There was no patient impact associated with this event.Additional information: perfusion and the sale rep thought that there may have been a unnoticeable crack on top of oxygenator where gas was escaping and thus the oxygenator was not adequately oxygenating.When the oxygenator was removed from the cvr the cap broke at the crack.The patient was up and walking around less than 24 hours post-op and is doing well following.

• Brand Name: AFFINITY NT BALANCE
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11559249
• MDR Text Key: 241930366
• Report Number: 2184009-2021-00013
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 511B
• Device Catalogue Number: 511B
• Device Lot Number: 13350051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2021
• 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): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 88