Affinity™ CP BBAP40 (UDI 00613994647856)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994647856), received between Oct 18, 2022 and Feb 2, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionFeb 2, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AFFINITY CENTRIFUGAL PUMP , IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A PUMP FAILURE. THE CENTRIFUGAL PUMP WAS RUNNING FINE UNTIL MOMENTS AFTER GIVING CARDIOPLEGIA. THE PUMP WAS AT 3000 RPMS WITH CI OF <(><<)>= 1.0, WHICH SHOULD NOT HAPPEN AT THAT RPM. THE CUSTOMER CHANGED IT OUT TO ANOTHER MANUFACTURER'S PUMP AND THINGS WERE FINE AFTER THAT. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED LOW FLOW PERFUSION SINCE CUSTOMER WAS UNABLE TO INCREASE CENTRIFUGAL PUMP FLOW. CARDIAC INDEX WAS <(><<)>= 1.0 WITH HIGH RPMS.THE CUSTOMER REPORTED THAT THE LONG TERM EFFECT WAS UNKNOWN AT THIS TIME SINCE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PUMP WAS USED IN AN AP40AST. THE CIRCUIT WAS REVIEWED AND THERE WERE NO CLAMPED LINES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630322 ↗
• MalfunctionApr 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE PERFUSIONIST WAS FLUID PRIMING THE CIRCUIT. DURING PRIMING THE CUSTOMER NOTICED A LEAK ON THE INLET SIDE OF THE AFFINITY CP PUMP HEAD. THE PUMP HEAD WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. THE CUSTOMER COULD NOT DETERMINE WHERE EXACTLY THE LEAK WAS BUT MENTIONED THE INLET OF THE CENTRIFUGAL CONE. THERE WAS NO VISIBLE AIR IN THE SYSTEM/TUBING. THERE WAS NO DAMAGE NOTED ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16741414 ↗
• MalfunctionFeb 8, 2023Obstruction of Flow; Noise, Audible; Obstruction of Flow; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CENTRIFUGAL PUMP, THE CUSTOMER REPORTED A VERY LOUD SQUEAL AND A BACKFLOW ALARMS STARTED. THE CUSTOMER THEN TURNED OFF CARDIOPLEGIA, THE PUMP WAS TURNED OFF, THEN ON AGAIN AND IT HAD FORWARD FLOW. THE CUSTOMER PREPARED THE HAND CRANK AND BEGAN CARDIOPLEGIA AGAIN, PUMP SQUEALED AND BACKWARD FLOW BEGAN FOR A SECOND TIME. THE CUSTOMER SEPARATED THE PUMP FROM AFFINITY CP ADAPTER PLATE AND THE ADAPTER PLATE WAS REMOVED TO PLACE ON THE HAND CRANK. THE CUSTOMER TRIED THE PUMP AGAIN AND THEY HAD FORWARD FLOW. THERE WERE NO ADVERSE PATIENT EFFECTS BECAUSE OF THIS ISSUE. THE CUSTOMER STATED THAT THE PATIENT'S CORE TEMPERATURE WAS 36.4 DEGREES CELSIUS AND TWICE THERE WAS NO FLOW TO PATIENT (10-20 SECONDS EACH). IT WAS APPROXIMATELY 1 MINUTE FROM THE FIRST ALARM TO THE LAST ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16321648 ↗
• MalfunctionOct 18, 2022Crack; Fluid/Blood Leak; Material Puncture/Hole; Crack; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT AFTER PRIMING AND THE ARTERIAL LINE WAS CONNECTED, A SMALL VOLUME OF FLUID WAS GIVEN BEFORE GOING ON BYPASS. THE CUSTOMER OBSERVED THAT BEFORE GOING ON BYPASS, A SMALL AMOUNT OF FLUID WAS UNDER THE CENTRIFUGAL PUMP HEAD. THE CUSTOMER INSPECTED THE CENTRIFUGAL PUMP HEAD AND OBSERVED WHAT APPEARED TO BE A LEAK FROM A CRACK AT THE TIP OF THE HEAD. THE DEVICE WAS REPLACED BY THE CUSTOMER CHANGING THE PUMP HEAD OUT AND THE REST OF THE CIRCUIT WAS USED WITHOUT ANY FURTHER INCIDENT TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SAME LEAK DID NOT APPEAR IN MULTIPLE CUSTOM TUBING PACKS. THERE WERE NO VISIBLE AIR IN SYSTEM/TUBING. THE PATIENT LOST 10ML OF BLOOD AT MOST AS A RESULT OF THIS LEAK. NO TRANSFUSION WAS REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15625421 ↗