NA HY8B05R7Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169930162), received between Nov 23, 2021 and Jun 20, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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

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.

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-1028-2023 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, WHEN PRIMING A LEAK WAS NOTED BETWEEN THE MALE LUER ON THE TRANSDUCER LINE AND THE FEMALE PORT ON TOP OF THE MYOTHERM (SEE ATTACHED DEVICE SPECIFICATION). THE TRANSDUCER LINE WAS REPLACED TO COMPLETE THE PROCEDURE. WHEN THE TRANSDUCER LINE WAS SWITCHED OUT THE LEAK STOPPED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EVENT OCCURRED. ADDITIONAL INFORMATION: THIS IS THE FIRST TIME THIS LEAK APPEARED BUT THEY HAVE HAD SEVERAL PROBLEMS WITH MYOTHERM IN THE PAST THAT WERE ALL REPORTED. NO AIR WAS IN THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17160851 ↗
• MalfunctionJul 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE CUSTOMER NOTED A SPRAYING LEAK FROM THE CARDIOPLEGIA LINE UPON PRIMING. THE CUSTOMER SWITCHED OUT THE CARDIOPLEGIA LINE WITH ONE FROM ANOTHER PACK. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15014195 ↗
• MalfunctionNov 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED BLOOD WAS LEAKING FROM THE END OF THE CARDIOPLEGIA LINE, THAT CONNECTS ON THE STERILE FIELD. IT WAS REPORTED THE LEAKING WAS FROM TUBING CONNECTED TO THE SOLID WHITE CONNECTOR. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 12859469 ↗