Fluid Management System P2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00860936000310), received between Jun 30, 2022 and Jan 10, 2025 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K091939, K133799); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2025Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT THERE WAS OVERPRESSURE DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21130826 ↗
• MalfunctionDec 6, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED MINOR COMPLICATION OF BLOOD CLOTS. THERE WAS NO MENTION OF ANY SIGNIFICANT DELAY OR TISSUE DAMAGE CREATED BY THE TRANSIENT DEVELOPMENT OF BLOOD CLOTS IN THE IRRIGANT. ONCE BLADDER IRRIGATION FLOW WAS RESTORED, THE BLOOD CLOTS WERE REPORTED TO RESOLVE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18279425 ↗
• InjuryJun 1, 2023Off-Label Use; Pressure Problem; Off-Label Use; Pressure Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TURP SYNDROME SYMPTOMS AND WAS ADMITTED TO THE ICU.

  Patient problems: Hyponatremia

  MAUDE report 17040432 ↗
• DeathJun 30, 2022Improper or Incorrect Procedure or Method; No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A PROCEDURE THE FLUID MANAGEMENT SYSTEM BAGS WERE SHOWING AS EMPTY. WHILE TRYING TO RECALIBRATE THE MACHINE THE PATIENT BECAME DISTRESSED AND A STAFF MEMBER ACCIDENTALLY UNPLUGGED THE MACHINE. THE ANESTHESIOLOGIST HAD TROUBLE ESTABLISHING AN AIRWAY AND THE PATIENT PASSED AWAY.

  Patient problems: Airway Obstruction; Distress; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14877463 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091939, K133799. One submission often covers many models, so check the product and lot details in each record.

• Z-1463-2015 · Sep 1, 2014 · Terminated
  Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures
• Z-2555-2014 · Feb 10, 2014 · Terminated
  The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operativ