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Affinity™ CP CBAP40 (UDI 20763000074412)Recalls & reported problems

Medtronic, Inc. · PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20763000074412), received between Mar 30, 2020 and Mar 30, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (1 report).

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

Device problems

  • Insufficient Flow or Under Infusion1
  • Noise, Audible1

Patient problems

  • Bradycardia1
  • Low Oxygen Saturation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 30, 2020Insufficient Flow or Under Infusion; Noise, Audible; Insufficient Flow or Under Infusion; Noise, Audible

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THE CBAP40 CENTRIFUGAL BLOOD PUMP IN THE VV-ECMO CIRCUIT, THE PUMP NEEDED TO BE CHANGED OUT AFTER RUNNING FOR 7-DAYS ((B)(6) 2020). THE HEALTHCARE PROFESSIONAL (HCP) WAS IN HOUSE MONITORING HIS PATIENT ON ECMO WHEN THE NURSE IN THE PATIENT'S ROOM CALLED HIM BECAUSE SHE STARTED TO HEAR A DISTINCT NOISE COMING FROM THE PUMP. WHEN THE HCP RETURNED TO THE ICU ROOM, THE PUMP WAS MAKING A SIGNIFICANT LOUD GRINDING NOISE, AS IF IT WAS GOING TO DECOUPLE. PUMP FLOW WAS ALSO REDUCED AND THE PATIENT SAT'S WERE DROPPING TO THE 70S AND HIS HEART RATE WAS BEGINNING TO BRADY DUE TO REDUCED FLOW FROM THE NOISY PUMP. HE CLAMPED OFF THE CIRCUIT, PULLED THE PUMP OFF AND RESEATED IT. HE RESTARTED THE PUMP AND IT FLOWED OK UNTIL THEY GOT ABOVE 4.0LPM. HE TRIED TO GET BACK TO FULL FLOW, WHICH WAS ABOVE 4.0LPM, BUT COULD NOT BECAUSE THE NOISE RETUNED. THE NOISE RETURNED WHEN FLOWS REACHED ABOVE 4.0LPM. NORMAL FLOW FOR PATIENT WAS 4.5-5.0LPM, WHICH THEY COULD NOT ACHIEVE WITHOUT THE PUMP MAKING NOISE. THE HCP THEN DECIDED TO CHANGE OUT THE MOTOR DRIVE TO SEE IF THAT WOULD RESOLVE THE ISSUE, BUT IT DID NOT RESOLVE THE NOISE. HE ALSO CLAMPED THE CIRCUIT OFF

    Patient problems: Bradycardia; Low Oxygen Saturation

    MAUDE report 9896813 ↗

Other Pump, blood, cardiopulmonary bypass, non-roller type devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.