Affinity Fusion® BB811Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00643169178168), received between Mar 25, 2019 and Nov 10, 2023 — classified as 7 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Material Separation” (60 reports).

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

5 other recalls cover devices cleared under the same FDA submission (K122827, 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-1023-2023 · Root cause: Process change control · FDA record ↗

2. Nov 16, 2016Terminated

   Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator.

   Z-0826-2017 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR, THE CUSTOMER REPORTED THAT THE CARDIOPULMONARY BYPASS CIRCUIT HAD BEEN PRIMED READY FOR THE CASE. THE CUSTOMER OBSERVED A FEW DROPS OF CLEAR FLUID ON THE FLOOR BENEATH THE OXYGENATOR. THE CUSTOMER THOUGHT IT WAS CONDENSATION OR DRIPS FROM THE HEATER COOLER LINE. ONCE THE PUMP SUCKERS WERE SWITCHED ON AND BLOOD WAS INTRODUCED INTO THE CIRCUIT THE DRIPS WERE INDICATIVE OF A BLOOD LEAK. THE CUSTOMER STATED THAT THEY COULD NOT PINPOINT THE EXACT AREA OF THE LEAK BUT BELIEVED IT WAS FROM THE CENTRAL DOME AT THE TOP OF THE OXYGENATOR. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER STATED THAT THE LEAK WAS FROM THE DEVICE ITSELF, NOT TUBING. THE CUSTOMER REPORTED THAT THEY WERE UNSURE OF EXACT LOCATION AS THE DRIPS WERE SEEN ON THE FLOOR. THE CUSTOMER DESCRIBED IT AS THE DOME AT THE TOP OF THE OXYGENATOR. THERE WAS NO DAMAGE TO THE DEVICE, THE PACKAGING OR OTHER CONTENTS WITHIN THE PACKAGE (EX. DEVICES IN A TRAY OR CUSTOM PACK). THE PATIENT LOST A FEW DRIPS, LESS THAN 10MLS, AS A RESULT OF THE

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

  MAUDE report 18109545 ↗
• MalfunctionNov 3, 2023Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT UNDER PRESSURE WHEN THE CIRCUIT WAS PRIMED THERE WAS A SPRAY OF PRIME NOTED WHEN THE OXYGENATOR MODULE FAILED TO DE-AIR APPROPRIATELY. THE SPRAY WAS COMING FROM THE RECIRCULATION PORT (NORMALLY THE PINK CAP PORT ON THE FUSION MODULE)  WHICH HAD 1/4" TUBING AND A CABLE TIE APPLIED BY THE CLEAN ROOM TEAM IN KERKRADE. THE CABLE TIE HAD DISPLACED DUE TO THE FLUID AND THEN THE PERFUSIONIST REAPPLIED A NEW CABLE TIE THE SPRAY OF PRIME CONTINUED. AT THIS TIME THE DECISION WAS MADE TO CHANGE OUT THE CIRCUIT AND THE OXYGENATOR. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18063792 ↗
• MalfunctionOct 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT DURING PRIMING THE DEVICE WAS LEAKING FLUID OUT OF THE TOP. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE NOTED ON THE DEVICE MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER REPORTED THAT THERE WAS NO ANTI-COAGULANT/CHEMICALS/DRUGS USED IN PRIME OR DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17918243 ↗
• MalfunctionAug 17, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, THE CUSTOMER REPORTED THAT WHILST SETTING UP THE PUMP THEY OBSERVED THAT THE TEMPERATURE PORT WAS LOOSE AND CAME APART WHEN THEY INSERTED THE TEMP PROBE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17563296 ↗
• MalfunctionJul 26, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF A FUSION OXYGENATOR, THE CUSTOMER REPORTED THAT AT THE END OF THE PROCEDURE, TH ERE WAS A PROBLEM WITH THE TEMPERATURE CONE THAT CAME WITH THE PROBE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 17395157 ↗
• MalfunctionJul 24, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE DURING SET-UP OF A FUSION OXYGENATOR,  THE CUSTOMER NOTICED THAT THE TEMPERATURE PROBE WAS NOT WELL SECURED. THE DEVICE WAS REPLACED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TEMPERATURE MONITORING ADAPTER (TMA) DETACHED FROM THE PORT WHEN THE PROBE WAS INSERTED, THE CUSTOMER NOTICED THAT IT WIGGLED AT THAT POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376775 ↗
• MalfunctionJul 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR IN A CARDIOPULMONARY BYPASS SURGERY, IT WAS REPORTED THAT THERE WAS A BLOOD LEAK FROM THE ARTERIAL SAMPLE PORT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT 10 ML OF PATIENT BLOOD WAS LOST BECAUSE OF THIS LEAK. A TRANSFUSION WAS NOT REQUIRED BECAUSE OF THIS LEAK. THERE WAS NO DAMAGE TO THE PACKAGING. THERE OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17305597 ↗
• MalfunctionJun 22, 2023Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR, THE CUSTOMER REPORTED THAT THE DEVICE WAS LEAKING AND FOAMING. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 17180287 ↗
• MalfunctionJun 16, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF A FUSION OXYGENATOR, THE CUSTOMER OBSERVED A LEAK FROM THE TEMPERATURE MONITORING ADAPTER (TMA). THIS WAS OBSERVED AFTER THE CASE DURING TEAR DOWN. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THERE WAS NO PATIENT BLOOD LOSS DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17141825 ↗
• MalfunctionJun 14, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT WHEN SETTING UP THE DEVICE AFTER PRIMING, THE CUSTOMER NOTED A PRIME LEAK FROM THE TEMPERATURE PORT ON THE ARTERIAL OUTLET OF THE OXYGENATOR. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER WAS AWARE OF THE FIELD SAFETY NOTICE ON THE PRODUCT AND WAS VERY CAREFUL WHEN ATTACHING THE TEMPERATURE PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17123916 ↗
• MalfunctionJun 13, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT THE POINT WHERE THE TEMPERATURE PORT WAS INSERTED CAME OFF. THE DEVICE WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TEMPERATURE MONITORING ADAPTER (TMA) WAS DETACHED FROM THE PORT BY ROTATING IT NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17116104 ↗
• MalfunctionJun 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS FUSION OXYGENATOR DURING ASSEMBLY OF THE CIRCULATION EXTRA-CORPORELLE (CEC) CIRCUIT, AFTER DE-BUBBLING THE CUSTOMER OBSERVED A PRIMING LEAK AT THE LEVEL OF THE OXYGENATOR BEFORE THE DEPARTURE IN CEC. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17085013 ↗
• MalfunctionJun 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT WATER WAS FOUND TO BE LEAKING AT THE WATER OUTLET CONNECTION AT THE LOWER END OF THE OXYGENATOR WHEN IT WAS PRE-FILLED WITH SALINE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17069179 ↗
• MalfunctionMay 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT BLOOD WAS DRIPPING INTERMITTENTLY FROM THE TEMPERATURE PORT. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO VISIBLE AIR NOTED IN THE SYSTEM/TUBING. THERE WAS A FEW SMALL DROPS OF PATIENT BLOOD LOSS. NO TRANSFUSION WAS REQUIRED AS A RESULT OF THIS LEAK.

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

  MAUDE report 16990686 ↗
• MalfunctionMay 24, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF A FUSION OXYGENATOR, IT WAS REPORTED POST CARDIOPULMONARY BYPASS (CPB), DURING BREAKDOWN OF THE PUMP, THAT THE TEMPERATURE PROBE ADAPTER PULLED OUT DURING REMOVAL OF THE TEMPERATURE PROBE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TEMPERATURE MONITORING ADAPTER (TMA) PULLED OUT OF THE DEVICE WHILE REMOVING THE TEMPERATURE PROBE. THE TMA WAS NOT LOOSE, THE USER DID NOT APPLY FORCE OR PRESSURE TO TEST THE TMA PRIOR TO USE. NO DAMAGE TO THE DEVICE WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16990665 ↗
• MalfunctionMay 18, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT THE PERFUSIONIST INFORMED THAT THE TE MPERATURE MONITORING ADAPTER (TMA) HAD COME LOOSE FROM THE DEVICE POST-PROCEDURE WHEN DISASSEMBLING THE PERFUSION CIRCUIT. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PROBLEM OCCURRED WHEN THE PERFUSIONIST WAS DISASSEMBLING THE DISPOSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16951817 ↗
• MalfunctionApr 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT THE CUSTOMER OBSERVED A LEAK IN THE ARTERIAL LINE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE ITSELF LEAKED. AT FIRST THE CUSTOMER REPLACED THE TUBING BUT THE LEAK STILL OCCURRED, THEN THEY DECIDED TO REPLACE THE DEVICE. THERE WAS NO DAMAGE TO THE DEVICE IDENTIFIED. THERE WAS NO DAMAGE TO THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16741651 ↗
• MalfunctionApr 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR ,  IT WAS REPORTED THAT DURING PRIMING THE PERFUSIONIST OBSERVED PRIME SOLUTION TO BE LEAKING OUT FROM THE TOP OF THE OXYGENATOR. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE CUSTOMER STATED THE SPECIFIC LOCATION OF THE LEAK COULD NOT BE IDENTIFIED. NO HEPARIN OR OTHER DRUGS WERE ADDED TO THE PRIME SOLUTION. THERE WERE NO NOTICEABLE CRACKS OR DAMAGE TO THE OXYGENATOR OR THE PACKAGING. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO OTHER CONTENTS WITHIN THE PACKAGE. THERE WAS NO AIR IN SYSTEM AND NO ADVERSE PATIENT EFFECTS, AS THE ISSUE OCCURRED DURING PRIMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16741468 ↗
• MalfunctionApr 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT DURING PRIMING THE ARTERIAL OUTPUT AT THE PURGE LINE OF THE AV LINE, DROPS OF PRIMING SOLUTION DRIPPED OUT. USE OF THE DEVICE WAS REQUESTED BUT IT WAS REPORTED AS ASKED BUT UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO VISUAL DAMAGE TO THE DEVICE, THE PACKAGING OR OTHER CONTENTS WITHIN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16672375 ↗
• MalfunctionMar 16, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT A TEMPERATURE PROBE WITH A KNOWN KINK WAS INSERTED INTO THE ARTERIAL TEMPERATURE PORT. THE CUSTOMER DID NOT LIKE THE POSITION OF THE OXYGENATOR AND REMOVED THE TEMPERATURE PROBE (WHICH HAD A KNOWN KINK IN IT) AND THE PROBE GOT STUCK INSIDE THE OXYGENATOR TEMPERATURE PORT. THE CUSTOMER USED SOME FORCE AND THE TEMPERATURE MONITORING PORT CAME OFF THE OXYGENATOR. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER USED FORCE TO REMOVE THE TEMPERATURE PROBE OUT OF THE TEMPERATURE MONITORING ADAPTER (TMA) AND THEN THE TMA DETACHED. THE EVENT HAPPENED DURING SETUP. THE CUSTOMER KNOWINGLY USED A TEMPERATURE PROBE THAT WAS BENT. IT GOT STUCK IN THE TMA PORT AND WHEN THEY TRIED TO PULL OUT THE TEMPERATURE PROBE, THE TMA CAME OUT WITH IT. THE CUSTOMER IS AWARE THAT THE PROBLEM WOULD NOT HAVE HAPPENED IF THE BENT TEMPERATURE PROBE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552432 ↗
• MalfunctionMar 16, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  ADDITIONAL INFORMATION RECEIVED BY MEDTRONIC THAT DURING UNPACKING AND PRIMING THE CIRCUIT THE CUSTOMER SAW WHEN CONNECTING THE TEMPERATURE PROBE THAT THERE WAS A LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16551621 ↗
• MalfunctionMar 9, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT THE TEMPERATURE MONITOR ADAPTER (TMA) PORT WAS VISIBLY INSPECTED AND WHEN THE TEMPERATURE PROBE ATP210 WAS GENTLY INSERTED THE PORT CAME AWAY FROM THE OXYGENATOR BODY WITH EASE. THE CUSTOMER STATED THE ISSUE WAS OBSERVED DURING SET UP AND BEFORE PRIMING, THERE WAS NO FORCE APPLIED AND THERE WAS NO DAMAGE TO ANY PACKAGING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THERE WERE TWO LOTS OF FUSION OXYGENATOR USED IN THE MANUFACTURE OF THIS CUSTOM TUBING PACK: 225199429 AND 225184613.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16511569 ↗
• MalfunctionMar 7, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, THE CUSTOMER WAS INSPECTING THE DEVICE DURING SETUP AND BEFORE PRIMING, THE TEMPERATURE MONITORING ADAPTER (TMA) PORT WAS VISIBLY INSPECTED AND WHEN THE TEMPERATURE PROBE ATP210 WAS GENTLY INSERTED THE PORT CAME AWAY FROM THE BODY OF THE DEVICE WITH EASE. THE OXYGENATOR WAS CUT OUT OF THE CUSTOM PACK AND REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. IT WAS ALSO REPORTED THAT NO FORCE WAS APPLIED AND THERE WAS NO DAMAGE TO ANY PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16494059 ↗
• MalfunctionMar 7, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A FUSION OXYGENATOR, THE CUSTOMER WAS INSPECTING THE DEVICE PRIOR TO USE. DURING SETUP AND BEFORE PRIMING, THE TMA PORT WAS VISIBLY INSPECTED AND WHEN THE TEMPERATURE PROBE ATP210 WAS GENTLY INSERTED THE PORT CAME AWAY FROM THE BODY OF THE DEVICE WITH EASE. THE OXYGENATOR WAS CUT OUT OF THE CUSTOM PACK AND REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. IT WAS ALSO REPORTED THAT NO FORCE WAS APPLIED AND THERE WAS NO DAMAGE TO ANY PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16494009 ↗
• MalfunctionFeb 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR, A LEAK WAS NOTED AT THE INLET OF THE OXYGENATOR MEMBRANE DURING HIGH-FLOW EXTRACORPOREAL CIRCULATION EVEN THOUGH THERE WERE NO ABNORMALITIES DEPRESSION. EXTRACORPOREAL CIRCULATION WAS CONTINUED AT A LOWER FLOW RATE, WHICH RESULTED IN PATIENT COOLING. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

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

  MAUDE report 16443038 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122827, 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-1025-2023 · Dec 12, 2022 · Open, Classified
  Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. 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-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.
• 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.