Cartridge Blood Set 103402Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07332414046835), received between Jun 19, 2020 and Jan 19, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS AN EXTERNAL BLOOD LEAK AT THE JUNCTION OF THE HEPARIN LINE AND THE ARTERIAL CHAMBER OF A CARTRIDGE EXTENDED DIALYZER LINE. THIS EVENT OCCURRED AT THE BEGINNING OF TREATMENT. THE BLOOD WAS NOT RETURNED TO THE PATIENT AND THE PATIENT LOST APPROXIMATELY 300ML OF BLOOD; HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11197071 ↗
• MalfunctionJan 19, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AT THE START OF TREATMENT USING AN HD CARTRIDGE BLOOD LINE, AN EXTERNAL BLOOD LEAK WAS OBSERVED AT THE JUNCTION OF THE HEPARIN AND THE ARTERIAL CHAMBER. THE PATIENT LOST APPROXIMATELY 200 ML OF BLOOD. THE EXTRACORPOREAL BLOOD WAS RETURNED TO THE PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11194274 ↗
• MalfunctionJun 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK (VOLUME NOT SPECIFIED) WAS OBSERVED FROM THE ARTERIAL PORT OF A CARTRIDGE SET DURING DIALYSIS TREATMENT. THIS WAS OBSERVED ON APPROXIMATELY 16-17 PATIENTS. IT WAS REPORTED THE BLOODLINE DISCONNECTED AT THE ARTERIAL MED PORT AND A LOW ARTERIAL PRESSURE ALARM WAS TRIGGERED. THE BLLO PUMP WAS REPORTED TO HAVE STOPPED DUE TO LOW ARTERIAL PRESSURE ALARM AND THE ARTERIAL CHAMBER WAS FILLED WITH AIR. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10174501 ↗