CombiSet 03-2922-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840861100323), received between Aug 6, 2019 and Aug 6, 2019 — 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

Recent adverse event reports

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

• MalfunctionAug 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED A BLOOD LEAK THAT OCCURRED AT THE BEGINNING OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED AT THE Y-SHAPED CONNECTION OF THE COMBI SET NEAR THE BLOOD PUMP. THE CONNECTIONS WERE TIGHT. THERE WAS NO DEFECT OR DAMAGED NOTICED ON THE COMBI SET. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS REPORTED AS MINIMAL; A FEW DROPS. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT SUCCESSFULLY COMPLETED TREATMENT ON THE SAME MACHINE WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8864965 ↗