Cartridge Blood Set 109536Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07332414085216), received between Aug 2, 2021 and Aug 2, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

2 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 30, 2020Class IIOpen, Classified

   complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

   Z-1121-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Apr 17, 2020Class IITerminated

   Potential disconnection of tubing set.

   Z-2194-2020 · Root cause: Process control · Recall details · FDA record ↗

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 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FOLLOWING THIRTY TO FORTY MINUTES OF TREATMENT, AN EXTERNAL BLOOD LEAK ORIGINATED FROM THE ¿BOTTOM OF THE LOOP WHERE THE LINE RECONNECTS TO THE SET' OF A GAMBRO CART ACCESS SITE PRIME. TREATMENT WAS RESTARTED WITH A NEW MACHINE AND SET OF DISPOSABLES AFTER TREATMENT WAS STOPPED FOR APPROXIMATELY TEN (10) TO FIFTEEN (15) MINUTES AND WAS COMPLETED WITHOUT AN ISSUE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12264361 ↗