enFlow 980200EURecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403286155), received between Mar 14, 2019 and Mar 14, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Particulates” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 14, 2019Particulates; Particulates

  AFTER BEING ALERTED TO POSSIBLY HIGH LEVELS OF ALUMINIUM BEING RELEASED INTO INFUSATE AFTER USE OF THE ENFLOW CARTRIDGE VIA GUARDIAN ARTICLE AND ANAESTHESIA PAPER, MIDDLEMORE HOSPITAL ELECTED TO CONDUCT THEIR OWN BENCH TESTING USING SALINE AND PLASMALYTE (BAXTER). SAMPLES WERE COLLECTED USING NO-TOUCH TECHNIQUE. SAMPLES SENT TO A LOCAL LAB (LABPLUS) FOR TRACE ELEMENT (ALUMINIUM) TESTING (TESTING PROTOCOL UNKNOWN). BASED ON THE RESULTS THEY FIND THE ALUMINIUM LEVELS UNREASONABLY HIGH AND ARE NOT USING THE ENFLOW ON ANY PATIENTS UNTIL A SUITABLE ALTERNATIVE IS FOUND.

  Patient problems: No Patient Involvement

  MAUDE report 8423047 ↗
• MalfunctionMar 14, 2019Particulates; Particulates

  A NEWS ARTICLE BY THE BMJ TITLED "ENFLOW FLUID WARMING DEVICE: WARNING OVER RISK OF ALUMINIUM TOXICITY" WAS PUBLISHED ON MARCH 11, 2019. THE ARTICLE MENTIONS A RECENT PAPER IN ANAESTHESIA THAT UNCOATED ALUMINIUM PLATES IN FLUID WARMING SYSTEMS, SUCH AS THOSE USED IN THE ENFLOW SYSTEM, YIELDED POTENTIALLY HARMFUL CONCENTRATIONS OF ALUMINIUM WHEN USING BALANCED ELECTROLYTE SOLUTIONS. LEAD RESEARCHER THORSTEN PERL, SENIOR CONSULTANT AT THE UNIVERSITY MEDICAL CENTRE (B)(6), TOLD THE BMJ THAT PATIENTS WITH IMPAIRED ALUMINIUM ELIMINATION FROM RENAL INSUFFICIENCY WERE AT RISK OF ADVERSE EVENTS. "AN EFFECTIVE COATING FOR ALUMINIUM CONTAINING MEDICAL DEVICES IN DIRECT CONTACT WITH FLUIDS SHOULD BE RECOMMENDED," HE SAID.

  Patient problems: No Patient Involvement

  MAUDE report 8423033 ↗
• MalfunctionMar 14, 2019Particulates; Particulates

  AN ARTICLE PUBLISHED BY ANAESTHESIA JOURNAL ON 21 FEBRUARY 2019 SUGGESTS THAT USING UNCOATED ALUMINIUM PLATES IN FLUID-WARMING SYSTEMS, SUCH AS WITH THE ENFLOW IV FLUID/BLOOD WARMING DEVICE, CAN LEAD TO A RISK OF ADMINISTERING POTENTIALLY HARMFUL CONCENTRATIONS OF ALUMINIUM WHEN BALANCED CRYSTALLOID SOLUTIONS ARE USED.

  Patient problems: No Patient Involvement

  MAUDE report 8423013 ↗
• MalfunctionMar 14, 2019Particulates; Particulates

  THE UNIVERSITY OF GÖTTINGEN COMPARED ALUMINIUM UNCOATED ENFLOW CARTRIDGES VS. COATED. THEY FOUND HIGH CONCENTRATION OF ALUMINIUM IN THE ENFLOW CARTRIDGES, WHEN USING A BALANCED INFUSION OF STERO FUND IN 1/1E. THE CUSTOMER REPORTED USING BALANCED INFUSION WITH AN UNCOATED CARTRIDGE COULD CAUSE HIGH ALUMINIUM CONCENTRATIONS ABOVE SPECIFICATION LIMITS WITH A POTENTIAL OF AN ACUTE ORGAN TOXIC INCIDENT FOR PATIENT WITH KIDNEY DYSFUNCTION. THE CUSTOMER REPORTED THE ALLEGATIONS WERE PERFORMED UNDER BENCH TESTING AND THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8422154 ↗