NA 6033765Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07332414075828), received between May 6, 2019 and Apr 11, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WERE THREE (3) SEPARATE INCIDENTS OF EXTERNAL FLUID LEAKS FROM 9 LITER EFFLUENT BAGS DURING USE ON THREE (3) PATIENTS. THE LEAKAGE OCCURRED ON BOTH SIDES OF THE BAG DRAIN VALVE. 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 19093075 ↗
• MalfunctionJul 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 9L EFFLUENT BAG WAS OBSERVED TO BE LEAKING ABOVE THE DRAINAGE CLAMP, AT THE TOP OF THE DRAINAGE TUBE. NO ALARMS WERE TRIGGERED. 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 15106175 ↗
• MalfunctionJul 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 9L EFFLUENT BAG WAS OBSERVED TO BE LEAKING ABOVE THE DRAINAGE CLAMP, AT THE TOP OF THE DRAINAGE TUBE. NO ALARMS WERE TRIGGERED. 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 15103477 ↗
• MalfunctionJul 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 9L EFFLUENT BAG WAS LEAKING AT THE "SEAM BETWEEN THE ACTUAL BAG AND THE PUMP TUBE THAT LEAKS". THE WARNING TAG WAS OBSERVED TO BE WET AND THE PINCH CLAMP WAS COMPLETELY CLOSED. NO ALARM WAS GENERATED. 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 14913744 ↗
• MalfunctionJul 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 9L EFFLUENT BAG WAS OBSERVED TO BE LEAKING AT THE PUMP CONNECTOR, FURTHER DESCRIBED AS SOMEWHERE BETWEEN THE DRAINAGE TUBE AND WHERE THE TUBE CONNECTED TO THE BAG. NO ALARMS WERE TRIGGERED. 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 14913742 ↗
• MalfunctionMar 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A 9L EFFLUENT BAG AT THE LEVEL OF THE WELD, DURING USE. 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 13653335 ↗
• MalfunctionMar 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A 9L EFFLUENT BAG AT THE LEVEL OF THE WELD, DURING USE. 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 13653326 ↗
• MalfunctionSep 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM TWO (2) 9L EFFLUENT BAGS DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE LEAK WAS OBSERVED TO BE COMING FROM A GAP AT THE BOTTOM OF THE BAG NEXT TO THE DRAIN (WHICH WAS APPROPRIATELY CLAMPED WITH BOTH INCIDENCES). IT WAS REPORTED THE LEAK WAS VERY SLOW WHILE THE BAG WAS HANGING ON THE SCALE BUT FLOWED MUCH FASTER WHEN THE PARTIALLY FILLED BAG WAS REMOVED AND THE DRAINAGE PORT WAS MOVED TO THE SIDE (MAKING THE GAP INTO A WIDER HOLE IN THE BOTTOM OF THE BAG). IT WAS REPORTED THE NURSE NOTICED THE LEAK AND CHANGED THE BAGS PRIOR TO THE MACHINE ALARMING. 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 10511095 ↗
• MalfunctionMay 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 9L EFFLUENT DRAIN BAG LEAKED FROM THE TOP FOLD OF THE BAG DURING ¿FILLING¿. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8582343 ↗
• MalfunctionMay 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 9L EFFLUENT DRAIN BAG LEAKED FROM THE TOP FOLD OF THE BAG DURING ¿FILLING¿. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8582278 ↗
• MalfunctionMay 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 9L EFFLUENT DRAIN BAG LEAKED FROM THE TOP FOLD OF THE BAG DURING ¿FILLING¿. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8582211 ↗