CombiSet 03-2696-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840861100286), received between Sep 23, 2020 and Sep 23, 2020 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionSep 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A HOME HEMODIALYSIS PATIENT REPORTED TO A FRESENIUS CANADIAN TECHNICIAN THAT A BLOODLINE LEAKED FROM THE Y-CONNECTOR AT THE TOP OF THE ARTERIAL CHAMBER. THE DATE OF THE EVENT WAS NOT PROVIDED IN THE INITIAL REPORTING. IT WAS REPORTED THAT THE LEAK WAS FOUND AT THE BEGINNING OF TREATMENT; HOWEVER, AN ESTIMATED BLOOD LOSS (EBL) VOLUME WAS NOT PROVIDED. THE SAMPLE WAS REPORTED TO BE AVAILABLE FOR A MANUFACTURER EVALUATION. NO FURTHER DETAILS WERE GIVEN. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, TO DATE A RESPONSE HAS NOT BEEN RECEIVED. ADDITIONAL FOLLOW-UP REVEALED THAT THE SAMPLE WAS DISCARDED, AND THEREFORE, NO LONGER AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10578170 ↗