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

Model Number 95212

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: visual inspection shows a crack in the upper hex housing.Pressure integrity testing was performed at 3 l/pm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.During the pressure integrity testing there was a leak observed at the crack.Reason for return was confirmed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the use of an affinity nt oxygenator, the customer observed a leak.The device was replaced to complete the procedure.There was no patient impact associated with this event.Medtronic received additional information that the amount of blood lost as a result of the leak was unknown.The patient did not require a transfusion because of the leak.Analysis of the returned device showed a crack in the upper hex housing of the device as the source of the reported leak.

• Brand Name: AFFINITY NT OXYGENATOR
• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14286813
• MDR Text Key: 290777676
• Report Number: 2184009-2022-00096
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2022
• Device Model Number: 95212
• Device Catalogue Number: 95212
• Device Lot Number: 13350063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1