MAUDE Adverse Event Report: PERFUSION SYSTEMS FUSION HFO CARMEDA COATED OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number CB811

Device Problem Increase in Pressure (1491)

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

Event Date 10/08/2021

Event Type  Injury  

Manufacturer Narrative

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, the customer reported that greatly elevated pressure occurred in the circuit (pre-oxygenator pressure) rapidly after about 5-7 min of the cpb. After checking the arterial cannula and circuit, an additional pressure was applied to the circuit (post-oxygenator pressure), which confirmed that a high pressure drop in the oxygenator has occurred. The problem was isolated to the oxygenator. Treatment with nitroprusside was started as treatment for the high blood pressure according to routine, but the high pressure drop persisted. Then was decided that the oxygenator needed to be replaced. Ecc was terminated, the oxygenator was changed as usual. During the oxygenator exchange, the patient had their own adequate circulation, and before exchange the cpb was stopped. Directly after the exchange, the cpb was started again. Ecc was started immediately after the change-out.  there was no patient impact associated with this event. Additional information: for about 10-15 minutes, the perfusion from the heart-lung machine could not deliver full flow. Throughout the process, the patient had their own supporting circulation. The prime volume was 1400ml of ringer-acetat with 10 000iu/heparin. Standard anesthesia drugs were used during the case. And nitroprusside when the pressure drop occurred. Initial pre oxygenator pressure was measured, and after the increased pressure, post oxygenator was also measured. The heparin dosing calculation was 400iu/kg, and act is aimed to 480sec. After bolus dose (45 000iu) the act was 494. After 5 min cpb it was 580 sec. Before oxygenator exchange another 10000iu was given, and after exchange the act was 1000sec. The temperatures pre and post oxygenator were as follows: pre oxy temp 34. 8c. Post oxy temp 34. 1c.

• Brand Name: FUSION HFO CARMEDA COATED
• 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: 12770425
• MDR Text Key: 280458446
• Report Number: 2184009-2021-00108
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K183490
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: CB811
• Device Catalogue Number: CB811
• Device Lot Number: 221398139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/08/2021 Patient Sequence Number: 1