NA 114423Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07332414112264), received between Feb 27, 2018 and Jul 12, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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. 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.

• MalfunctionJul 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED ORIGINATING FROM SEAM OF THE GAMBRO 5L EFFLUENT BAG DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17312585 ↗
• InjuryAug 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5 L EFFLUENT BAG WAS OBSERVED TO BE LEAKING DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). THERAPY WAS BEING PERFORMED WITH A PRISMAFLEX MACHINE VIA EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), CONNECTED WITH A PRISMAFLEX SET. IT WAS REPORTED THAT UPON CHANGING THE EFFLUENT BAG, THE RIGHT ATRIAL PRESSURE STARTED TO DECREASE TO NEGATIVE NUMBERS, THE ECMO CIRCUIT WAS CUTTING OUT AND THE VENOUS NEGATIVE PRESSURE FROM ECMO BECAME TOO NEGATIVE AND THE PATIENT FLOW FROM ECMO DECREASED. THE PATIENT BECAME HYPOTENSIVE AND WAS TREATED WITH A BOLUS OF 60 ML OF NORMAL SALINE. THE EFFLUENT BAG WAS OBSERVED TO BE LEAKING IN SPITE OF THE OUTLET VALVE BEING COMPLETELY CLOSED. A NEW BAG WAS USED TO CONTINUE WITH THERAPY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 15162667 ↗
• MalfunctionFeb 28, 2018Disconnection; Leak/Splash; Disconnection; Leak/Splash

  THE CUSTOMER OBSERVED A LEAKAGE FROM THE CONNECTION PORT OF A 5L EFFLUENT DRAIN BAG DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7303982 ↗
• MalfunctionFeb 27, 2018Disconnection; Leak/Splash; Disconnection; Leak/Splash

  THE CUSTOMER OBSERVED A LEAKAGE FROM THE CONNECTION PORT OF A 5L EFFLUENT DRAIN BAG DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7300459 ↗