Affinity Fusion™ BB811Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000834210), received between Jul 14, 2023 and Jun 18, 2024 — classified as 2 deaths, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT FOLLOWING PRIMING OF THE SYSTEM BUT PRIOR TO IT BEING CONNECTED TO THE PATIENT THE OXYGENATOR BEGAN LEAKING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE ITSELF LEAKED. THE LEAK WAS FROM THE ARTERIAL LINE PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558477 ↗
• MalfunctionJun 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR, IT WAS REPORTED THERE WAS A CONNECTOR ISSUE. THE ISSUE WAS THE RED DIALYSE CONNECTOR. THE CONNECTOR WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT A LEAK OCCURRED. THERE WAS NO DAMAGE OBSERVED TO THE DEVICE. THERE WAS NO DAMAGE TO THE PACKAGING (OUTER BOX, INNER PACKAGING OR STERILE BARRIER). OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19546692 ↗
• MalfunctionMay 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT THE CUSTOMER NOTICED A SUBSTANTIAL PRIME FLUID LEAK COMING FROM THE TOP OF THE DEVICE UPON PRIMING THE DEVICE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE DEVICE, THE PACKAGING OR OTHER CONTENTS WITHIN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19403333 ↗
• MalfunctionApr 10, 2024Crack; Air/Gas in Device; Crack; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT AIR WAS DETECTED IN THE MEMBRANE OXYGENATOR, THE CUSTOMER SUSPECTED THAT THE CAUSE OF AIR FORMATION MAY BE DUE TO A CRACK. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077562 ↗
• MalfunctionApr 8, 2024Gas Output Problem; Gas/Air Leak; Gas Output Problem; Gas/Air Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT DURING CARDIOPULMONARY BYPASS THE PERFUSIONIST WAS UNABLE TO GET CO2 LEVELS BELOW 50. THE PERFUSION HOOKED THE OXYGENATOR UP STRAIGHT TO BOTTLED O2 WITH NO CHANGE. THE PROCEDURE WAS COMPLETED WITH THIS OXYGENATOR. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE OBSERVED TO THE OXYGENATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19058649 ↗
• MalfunctionFeb 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, THE CUSTOMER REPORTED DRIPS FALLING FROM THE ONTO THE FLOOR. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE WAS LEAKING FROM THE GAS OUTLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18745639 ↗
• DeathFeb 1, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR, THE CUSTOMER REPORTED THAT THERE WAS A THROMBOSIS INCIDENT. THE PROCEDURE WAS AN AORTIC DISSECTION. USE OF THE OXYGENATOR WAS CONTINUED. THE PATIENT HAS EXPIRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT'S CAUSE OF DEATH WAS ENCEPHALIC DEATH DUE TO MULTIPLE ISCHEMIC STROKES. THE CUSTOMER STATED THAT THE OXYGENATOR DID NOT FAIL IN ITS ABILITY TO OXYGENATE THE PATIENT CORRECTLY BUT IT WAS RESPONSIBLE FOR THE MULTIPLE STROKES SEEN IN THE PATIENT. THE CUSTOMER STATED THAT THE PERFORMANCE PROBLEM CAUSED OR CONTRIBUTED TO THE DEATH AS IT RESULTED IN THE EMBOLIC STROKES. THE CUSTOMER STATED THAT THE THROMBOTIC PROCESS WAS VISUALIZED ON THE ONLY OBSERVABLE FACE OF THE OXYGENATOR, IN THE SPACE AFTER THE IMMEDIATE OXYGENATOR FIBERS. AS THE PLANNED OPERATION WAS PERFORMED UNDER NORMOTHERMIC CONDITIONS, ONLY THE ARTERIAL LINE TEMPERATURE WAS MONITORED. THE LOWEST TEMPERATURE WAS 34.4°C. THE CUSTOMER STATED THAT THEY DO NOT KNOW WHETHER THE THROMBOTIC PROCESS DEVELOPED SLOWLY OR SUDDENLY. IT WAS NOTED APPROXIMATELY 50 MINUTES AFTER STARTING THE BYPASS. A PROBLEM WITH THE OXYGENATOR WAS SUSPECTED BECAUSE THE

  Patient problems: Stroke/CVA

  MAUDE report 18621019 ↗
• DeathNov 6, 2023Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT DURING EXTRACORPOREAL CIRCULATION (CEC), IT WAS IMPOSSIBLE TO RAISE THE PATIENT'S PRESSURE, AND THERE WAS A CLOT COVERING 80% OF THE SURFACE OF THE MEMBRANE. THE CUSTOMER WAS UNABLE TO DELIVER TO THE ARTERIAL PUMP. IT WAS REPORTED THAT THE MEMBRANE THROMBOSIS CAUSED THE PATIENT TO HAVE AN ISCHEMIC STROKE. IT WAS REPORTED THAT THE PATIENT DIED DUE TO CEREBROVASCULAR ATTACK (CVA) THREE DAYS LATER. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE THROMBUS APPEARED ALMOST INSTANTLY. THE PERFUSIONIST WANTED TO OBTAIN A FLOW RATE ON THE PUMP OF 5L/MIN, AND THE FLOW METER ONLY SHOWED 3L/MIN, WITH THE PATIENT'S MEAN ARTERIAL PRESSURE (MAP) REMAINING VERY LOW AT AROUND 20-30MMHG. HEPARIN PLUS ACT CONTROL WAS USED AS AN INTERVENTION TO MANAGE THROMBUS FORMATION. THE TEMPERATURES OF THE ARTERIAL AND VENOUS LINES OF THE OXYGENATOR WERE BLOOD TEMPERATURE 35.5° CELSIUS AND VENOUS TEMPERATURE AT 35° CELSIUS. THE CUSTOMER STATED THAT THE FIBRIN DEVELOPED SUDDENLY. THERE WAS NO USE OF VACUUM ASSISTED VENOUS DRAINAGE (VAVD) AND NO AIR ENTERED THE VEIN. AN OPEN CIRCUIT MEDTRONIC FUSION WAS USED. HEPARIN DOSA

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 18072371 ↗
• MalfunctionOct 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT THE DEVICE LEAKED DURING PRIMING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LEAK WAS ON THE DEVICE ITSELF. THE CUSTOMER BELIEVES THE LEAK WAS AROUND THE UPPER SEAL ON THE OXYGENATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875359 ↗
• MalfunctionAug 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT DURING PREPARATION OF THE BYPASS, THERE WAS A LEAKAGE FROM THE DEVICE IDENTIFIED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17583159 ↗
• MalfunctionJul 14, 2023Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, THE CUSTOMER REPORTED THAT THE DEVICE WAS CRACKED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17323293 ↗