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B-CAPTA 3/8" ARTERIAL CUVETTERecalls & reported problems

Sorin Group Italia Srl · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033178113526), received between Jun 21, 2023 and Jun 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

  • Fluid/Blood Leak1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJun 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, AFTER 4 MINUTES HAVING INTIATED A BYPASS, A LEAK WAS OBSERVED FROM THE BCAPTA ARTERIAL CUVETTE 3/8. ACCORDING TO PROVIDED PICUTURES, THE LEAK WAS FROM THE METAL PLATE COVERING THE MEMBRANE. CUVETTE WAS CHANGED OUT, BLOOD LOSS WAS NEARLY ONE (1) LITER AND MEDICAL TEAM ELECTED TO COMPENSATE IT WITH 1L PLASMA EXPANDER. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17168653 ↗

Other MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS devices

All MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS devices →

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