Affinity Fusion™ CB811 (UDI 00763000225476)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000225476), received between Nov 29, 2022 and Mar 20, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K183490, K203111); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 12, 2022Open, Classified

   An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.

   Z-1025-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, THE CUSTOMER REPORTED THAT THE DEVICE WAS SET UP AND WATER TESTED. UPON TURNING THE HEATER/COOLER ON IN ORDER TO WATER TEST THE DEVICE, THE CUSTOMER NOTED WATER SPRAYING OUT OF THE GAS EXHAUST PORT. THE DEVICE WAS REPLACED IMMEDIATELY TO RUN THE CASE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE DEVICE OR PACK/PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18938846 ↗
• MalfunctionNov 28, 2023Fluid/Blood Leak; Gas Output Problem; Fluid/Blood Leak; Gas Output Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CARMEDA FUSION HOLLOW FIBER OXYGENATOR, IT WAS REPORTED THAT DURING SURGERY WITH ECC, THE DEVICE WORKED POORLY. CO2 WAS DELIVERED TO THE OPEN CHEST, AND THE OXYGEN DELIVERY WAS GOOD. BUT THEN THE CARBON DIOXIDE VENTILATION BEGAN TO DETERIORATE SIGNIFICANTLY FROM THE NORMAL SPEED OF 3-4 LITERS OF FRESH GAS FLOW. 13 LITERS ARE REQUIRED TO KEEP PCO2 BELOW 6KPA. THE DEVICE COULD ONLY DELIVER 10 LITERS, SO AN EXTRA FRESH GAS HOSE WAS SPLICED ONTO THE EXISTING ONE, AND 3 LITERS WAS THEN SUPPLIED FROM THE ANESTHESIA MACHINE'S ROTAMETER. ANESTHETIC GAS ALSO LEAKED FROM THE OXYGENATOR, AND THIS FORCED CUSTOMER TO CHANGE THE ANESTHESIA STRATEGY TO PROPOFOL INFUSION. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18215055 ↗
• MalfunctionJun 15, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT THE ARTERIAL TEMPERATURE PROBE FOR THE OXYGENATOR CAME LOOSE WHEN DISASSEMBLING THE DISPOSABLE PRODUCTS FROM THE HEART LUNG MACHINE POST-OP. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17136573 ↗
• MalfunctionNov 29, 2022Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF A FUSION HOLLOW FIBER OXYGENATOR, THE CUSTOMER REPORTED THAT THE TEMPERATURE PORT ON THE DEVICE CAME OUT COMPLETELY FROM THE MOLDING WHEN UNSCREWING THE PROBE FROM THE TEMP PORT. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT SINCE THE CARDIOPULMONARY BYPASS PART OF THE CASE WAS COMPLETELY OVER. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT WAS NOT CONNECTED TO THE PERFUSION PUMP IN ANY WAY WHEN THE TEMPERATURE PORT BECAME LOOSE AND CAME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15876368 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183490, K203111. One submission often covers many models, so check the product and lot details in each record.

• Z-1026-2023 · Dec 12, 2022 · Open, Classified
  Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
• Z-1028-2023 · Dec 12, 2022 · Open, Classified
  Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
• Z-1023-2023 · Dec 12, 2022 · Open, Classified
  Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
• Z-1027-2023 · Dec 12, 2022 · Open, Classified
  Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
• Z-1024-2023 · Dec 12, 2022 · Open, Classified
  Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.