AUTO EFFLUENT SET 115370Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07332414118914), received between Mar 8, 2023 and May 24, 2024 — 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 16, 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.

• MalfunctionMay 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE PERFORMING CONTINUOUS RENAL REPLACEMENT THERAPY, A PRISMAX AUTO EFFLUENT BAG WAS LEAKING AT THE JUNCTION OF THE BAG AND THE TUBING. TO RESOLVE THIS ISSUE, THE EFFLUENT BAG WAS REPLACED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397871 ↗
• MalfunctionMar 8, 2023Fluid/Blood Leak

  THE PATIENT WAS RECEIVING CONTINUOUS RENAL REPLACEMENT THERAPY WITH BAXTER HEALTHCARE PRISMAX MACHINE. THE RN NOTICED EFFLUENT LEAKING FROM THE SMALL 1-LITER BAG OF THE AUTO EFFLUENT ACCESSORY KIT. IMMEDIATELY, THE RN STOPPED THERAPY AND REPLACED THE CRRT TUBING (PRISMAFLEX EXTRA CORPOREAL CIRCUIT WITH FILTER, THERMAX BLOOD WARMER AND AUTO EFFLUENT ACCESSORY KIT. THE REPLACEMENT PROCESS DELAYS THERAPY FOR AT LEAST 20 MINUTES. THE FLUID WAS LEAKING FROM THE JUNCTION OF TUBING AND BAG (PICTURES AVAILABLE). THE BAXTER REP WILL BE REMOVING ALL AUTO EFFLUENT ACCESSORY PRODUCTS WITH LOT # 22H2901 AND REPLACING WITH NEW PRODUCTS.

  Patient problems: Insufficient Information

  MAUDE report 16501519 ↗
• MalfunctionMar 8, 2023Protective Measures Problem

  THE PATIENT WAS RECEIVING CRRT, AND THE RN NOTICED EFFLUENT DRIPPING FROM THE 1-LITER AND 5-LITER BAGS. THE AUTO-EFFLUENT DRAIN ACCESSORY CONTINUOUSLY PUMPS EFFLUENT COLLECTED DURING THERAPY INTO A DRAIN, WHILE PROVIDING THE ACCURACY OF A SCALE-BASED MEASUREMENT SYSTEM. ELIMINATING EFFLUENT BAG CHANGES MINIMIZES USER EXPOSURE TO EFFLUENT. THE LOSS OF EFFLUENT CAN AFFECT THE PATIENT'S THERAPY AND INCREASE EXPOSURE OF HEALTHCARE WORKER TO EFFLUENT. THE RN HAD TO COMPLETELY REMOVE THE CURRENT CRRT SET PRISMAFLEX EXTRA CORPOREAL CIRCUIT WITH FILTER, THERMAX BLOOD WARMER, AND AUTO EFFLUENT DRAIN ACCESSORY. THE MACHINE WOULD NOT ALLOW THE RN TO ONLY REPLACE THE AUTO EFFLUENT DRAIN ACCESSORY. CHANGING OF THE TUBING CAUSES A DELAY IN THERAPY FOR AT LEAST 20 MINUTES. ALSO, THE COST INCREASES BECAUSE THE CRITICAL CARE UNIT HAS TO UTILIZE ANOTHER SET EARLY. THE BAXTER REP TOLD THE LEADERSHIP TO REMOVE ALL SETS WITH THE LOT # 22H2901. THE REP WILL TAKE THE TUBING WITH LOT # 22H2901 AND REPLACE WITH A NEW LOT #.

  Patient problems: Insufficient Information

  MAUDE report 16501478 ↗