FMS 284504Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 10886705017393), received between Apr 6, 2018 and May 20, 2024 — classified as 1 injury, 80 malfunctions.

The most frequently reported specific device problem is “Overfill” (30 reports).

3 other recalls cover devices cleared under the same FDA submission (K951843); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE SCOPE PROCEDURE ON (B)(6) 2024 IT WAS OBSERVED THAT THE IRRIGATION TUBESET DEVICE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) WAS CAUSING THE PUMP TO READ HIGH PRESSURE AND THE DEVICE HAD BAD TUBING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SLIGHT DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352379 ↗
• MalfunctionMay 20, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT DURING KNEE SCOPE PROCEDURE ON (B)(6) 2024 THE IRRIGATION TUBESET DEVICE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) WAS CAUSING THE PUMP TO READ HIGH PRESSURE AND HAD BAD TUBING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352295 ↗
• MalfunctionMay 20, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2024 IT WAS OBSERVED THAT THE IRRIGATION TUBESET DEVICE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) WAS CAUSING THE PUMP TO READ HIGH PRESSURE AND THE DEVICE HAD BAD TUBING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SLIGHT DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351324 ↗
• MalfunctionApr 24, 2024Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER SCOPE PROCEDURE ON 3/10/2024 IT WAS OBSERVED THAT THE IRRIGATION TUBESET DEVICE CHAMBERS OVERFILLED AND WATER WENT TO THE SENSOR VALVE ON TUBING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A THREE MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19171308 ↗
• MalfunctionMar 13, 2024Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGICAL PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) HAD THE PUMP FILL CHAMBER KEPT FILLING UP AND SHUTTING THE PUMP THEN GOING TO LOW PRESSURE MODE. THEY CHANGED THE PUMP WITH NO RESOLUTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE WITH A COUPLE OF MINUTES SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896302 ↗
• MalfunctionMar 6, 2024Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE FMS FLUID MANAGEMENT SYSTEM INFLOW TUBING (FMS DUO+ OR FMS SOLO) HAD THE PUMP FILL CHAMBER KEPT FILLING UP AND SHUTTING THE PUMP THEN GOING TO LOW PRESSURE MODE. THEY CHANGED THE PUMP WITH NO RESOLUTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE WITH A COUPLE OF MINUTES SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18849511 ↗
• MalfunctionMar 6, 2024Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGICAL PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) HAD THE PUMP FILL CHAMBER KEPT FILLING UP AND SHUTTING THE PUMP THEN GOING TO LOW PRESSURE MODE. THEY CHANGED THE PUMP WITH NO RESOLUTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE WITH A COUPLE OF MINUTES SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18849505 ↗
• MalfunctionJan 25, 2024Overfill; Overfill

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE CHAMBER ON THE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) DEVICE FILLED UP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18579834 ↗
• MalfunctionNov 8, 2023Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP IN ISRAEL THAT DURING A SHOULDER ARTHROSCOPY SURGICAL PROCEDURE ON AN UNKNOWN DATE, WHILE USING AN FMS DUO PUMP DEVICE, THE SALINE CHAMBER FILLED ALL WAY UP TWO DIFFERENT SETS OF INFLOW TUBING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18094239 ↗
• MalfunctionNov 8, 2023Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP IN ISRAEL THAT DURING A SHOULDER ARTHROSCOPY SURGICAL PROCEDURE ON AN UNKNOWN DATE, WHILE USING AN FMS DUO PUMP DEVICE, THE SALINE CHAMBER FILLED ALL WAY UP TWO DIFFERENT SETS OF INFLOW TUBING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093557 ↗
• MalfunctionNov 8, 2023Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP IN ISRAEL THAT DURING A SHOULDER ARTHROSCOPY SURGICAL PROCEDURE ON AN UNKNOWN DATE, WHILE USING AN FMS DUO PUMP DEVICE, THE SALINE CHAMBER FILLED ALL WAY UP TWO DIFFERENT SETS OF INFLOW TUBING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093492 ↗
• MalfunctionJun 27, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED BY THE DISTRIBUTOR IN BRAZIL THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) DEVICE DID NOT WORK PROPERLY. ACCORDING TO THE REPORT, IT WAS NOT GIVING PRESSURE AND THE SERUM FLOW. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17212686 ↗
• MalfunctionMar 10, 2023Increase in Pressure; Difficult or Delayed Separation; Increase in Pressure; Difficult or Delayed Separation

  IT WAS REPORTED BY SALES REP THAT DURING A LEFT KNEE ARTHROSCOPY PROCEDURE WITH PATELLAR CONDULARPLASTY ON (B)(6)2023, IT WAS OBSERVED THAT WHEN THEY WENT TO PLUG IN THE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) DEVICE INTO THE MACHINE, THERE WAS TOO MUCH PRESSURE AND THE CORD WAS NOT HOLDING IN PLACE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 15 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16523994 ↗
• MalfunctionSep 6, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN HONG KONG THAT THE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15364750 ↗
• MalfunctionAug 11, 2022Overfill; Output Problem; Overfill; Output Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN FRANCE THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT WHILE PURGING THE "GREEN NOTCH" FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) DEVICE, THE RESERVOIR FILLED-UP COMPLETELY THEN THE PUMP WENT INTO ALARM. ACCORDING TO THE REPORT, THE PUMP WAS CHANGED AND THE SAME PROBLEM OCCURRED WITH ANOTHER SET OF TUBING DEVICE FROM THE SAME LOT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15212923 ↗
• MalfunctionAug 11, 2022Overfill; Output Problem; Overfill; Output Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN FRANCE THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT WHILE PURGING THE "GREEN NOTCH" FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) DEVICE, THE RESERVOIR FILLED-UP COMPLETELY THEN THE PUMP WENT INTO ALARM. ACCORDING TO THE REPORT, THE PUMP WAS CHANGED AND THE SAME PROBLEM OCCURRED WITH ANOTHER SET OF TUBING DEVICE FROM THE SAME LOT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15212712 ↗
• MalfunctionJun 15, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) DEVICE WAS FAULTY AND LEAKING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14697140 ↗
• MalfunctionJun 15, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) DEVICE WAS FAULTY AND LEAKING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14697086 ↗
• MalfunctionFeb 16, 2022Crack; Leak/Splash; Moisture Damage; Crack; Leak/Splash; Moisture Damage

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ARTHROSCOPY SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE IRRIGATION TUBESET DEVICE WAS PERFORATED ON THE FLEXIBLE PART AT THE PUMP SHAFT AFTER 35 MINUTES OF USE. IT WAS FURTHER REPORTED THAT JUST AFTER AN IRRIGATION BAG REPLACEMENT, THERE WAS SALINE DRIPPING ON SENSITIVE ELECTRICAL EQUIPMENT (ARTHROSCOPY COLUMN). THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13542371 ↗
• MalfunctionJul 27, 2021Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2021, IT WAS OBSERVED THAT THE CHAMBER ON THE PUMP STARTED TO FILL UP AND A HIGH PRESSURE CODE WAS DISPLAYED. IT WAS REPORTED THAT A LOT OF SOLUTION WAS SQUIRTING OUT FROM THE JOINT. ACCORDING TO THE REPORT, AFTER REPLACING THE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) THE ERROR CODE WAS CLEARED AND THE ISSUE OF THE CHAMBER GOT SOLVED. THE PROCEDURE WAS COMPLETED WITH A DELAY OF LESS THAN FIVE MINUTES. THERE WERE NO ADVERSE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233857 ↗
• MalfunctionJul 12, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE IRRIGATION TUBE DEVICE HAD A HOLE AND A TEAR THAT IT WAS LEAKING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12154652 ↗
• MalfunctionJun 10, 2021Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED BY THE CUSTOMER THAT THE FMS FLUID MANAGEMENT SYSTEM/INFLOW TUBING (FMS DUO+ OR FMS SOLO) WAS TORN AND POURING WATER. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11975642 ↗
• MalfunctionApr 8, 2021Overfill; Overfill

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE CHAMBER ON THE IRRIGATION DEVICE OVERFLOWED WHILE SETTING-UP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11634316 ↗
• MalfunctionApr 7, 2021Overfill; Overfill

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE CHAMBER ON THE IRRIGATION TUBING SET DEVICE FILLED UP FULLY. ANOTHER PUMP DEVICE WAS USED TO WITH ANOTHER TUBING DEVICE. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11629105 ↗
• MalfunctionOct 23, 2020Residue After Decontamination; Residue After Decontamination

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT PREOPERATIVELY TO A ARTHROSCOPIC SUBACROMIAL DECOMPRESSION (ASAD) PROCEDURE, IT WAS OBSERVED THAT THE TUBING WAS SPLIT WHEN CONNECTED TO MACHINE WHILE THE PACKAGING WAS INTACT. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE TUBING HAD RESIDUES OF SALINE WATER. THERE WAS NO DELAY IN THE SURGERY DUE TO THE EVENT. ANOTHER SET OF TUBING WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10726441 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951843. One submission often covers many models, so check the product and lot details in each record.

• Z-0191-2014 · Aug 29, 2013 · Terminated
  DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to
• Z-1946-2011 · Dec 3, 2010 · Terminated
  DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing Product Code: 281142 Fluid Tissue Management
• Z-1948-2011 · Dec 3, 2010 · Terminated
  DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box) (International Distribution Only) Product Code: 281102 Fluid Tissue Management