Optiflux® Ultra 0500418ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840861100194), received between Jun 1, 2018 and Feb 6, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2023Fluid/Blood Leak

  HEAD OF DIALYZER FOUND TO BE LEAKING ONTO THE FLOOR WHICH APPEARED TO BE LEAKING AT THE SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303358 ↗
• MalfunctionNov 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A HEMODIALYSIS (HD) CLINIC DISTRIBUTION CENTER REPORTED THAT A BLOOD LEAK OCCURRED AT THE CROSS THREADED CONNECTION BETWEEN THE BLOODLINES AND THE DIALYZER IMMEDIATELY AFTER THE INITIATION OF HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED AS BLOOD REACHED THE DIALYZER VIA THE ARTERIAL LINE. THE MACHINE, A FRESENIUS 4008 S MACHINE, ALARMED FOR UNKNOWN REASONS AND THE PATIENT WAS USING A FRESENIUS DIALYZER. EVEN THOUGH NO LOOSE CONNECTIONS WERE FOUND, THE LEAK WAS DUE TO NOT BEING ABLE TO SECURELY CONNECT TO THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 1 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE NURSE STATED THAT WHEN THE LEAK WAS NOTICED, THE TREATMENT WAS DISCONTINUED AND THEN RESTARTED ON A DIFFERENT MACHINE WITH NEW SUPPLIES. THERE WERE NO CHANGES DURING TREATMENT AS WELL AS NOTHING NOTICED DURING PRIMING. THE NURSE CONFIRMED THERE WERE NO CHANGES OR DISRUPTION IN PRESSURE THAT COULD HAVE CAUSED THE ISSUE OR FOR THE MACHINE TO ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861694 ↗
• MalfunctionSep 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED IMMEDIATELY INITIATING THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER TO DATE NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9082138 ↗
• MalfunctionJun 1, 2018Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED ONE HOUR AND HALF INTO THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK. THE LEAK WAS VISUALLY OBSERVED IN THE FIBERS OF THE DIALYZER. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 150 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7560322 ↗