NA 7211007Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010543608), received between Mar 1, 2018 and Jul 14, 2022 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, A TOTAL OF TWO (2) DYONICS 25 DAY TUBE SETS CAUSED SEVERE BLOWING UP OF THE KNEE JOINT TO THE POINT THAT THE SURGEON WAS VERY WORRIED ABOUT PATIENT SAFETY. IT WAS A CONSTANT PROBLEM OF PUMPING WAY TOO MUCH. SWITCHING OUT THE DAY TUBE CASSETTE FIXED THE ISSUE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Extravasation

  MAUDE report 15013968 ↗
• InjuryJul 11, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, A DYONICS 25 DAY TUBE SET (3) CAUSED SEVERE BLOWING UP OF THE KNEE JOINT TO THE POINT THAT THE SURGEON WAS VERY WORRIED ABOUT PATIENT SAFETY. IT WAS A CONSTANT PROBLEM OF PUMPING WAY TOO MUCH. SWITCHING OUT THE DAY TUBE CASSETTE FIXED THE ISSUE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Extravasation

  MAUDE report 14983425 ↗
• InjuryJul 11, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, A DYONICS 25 DAY TUBE SET (3) CAUSED SEVERE BLOWING UP OF THE SHOULDER JOINT TO THE POINT THAT THE SURGEON WAS VERY WORRIED ABOUT THE PATIENT'S SAFETY. IT WAS A CONSTANT PROBLEM OF PUMPING WAY TOO MUCH. SWITCHING OUT THE DAY TUBE CASSETTE FIXED THE ISSUE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Extravasation

  MAUDE report 14983422 ↗
• MalfunctionNov 25, 2021Excess Flow or Over-Infusion; Noise, Audible; Excess Flow or Over-Infusion; Noise, Audible

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY, THE DYONICS 25 DAY TUBE PUMPED AN EXTREMELY LARGE AMOUNT OF LIQUID AND WAS EXTREMELY LOUD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12875250 ↗
• MalfunctionMay 26, 2021Leak/Splash; Component Missing; Leak/Splash; Component Missing

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION FOR AN ARTHROSCOPY THE SEALING RINGS OF THE DYONICS 25 DAY TUBE SET WERE MISSING, SO THAT ALL THE FLUSHING LIQUID RUSHED THROUGH AND GOT DIRECTLY INTO THE SYSTEM. THERE WAS A S+N BACK-UP DEVICE. NO DELAY WAS REPORTED, AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882928 ↗
• MalfunctionMar 31, 2021No Flow; No Flow

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE DYONICS 25 DAY TUBE SET AND DYONICS 25 PATIENT TUBE SET CAVITY HAD NO PRESSURE AND IT DID NOT WORK AS EXPECTED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO FURTHER COMPLICATIONS. THERE WAS A DELAY EQUAL TO OR LESS THAN 30 MINUTES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11596957 ↗
• MalfunctionMay 19, 2020Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT THE PUMP DISPLAYED AN ¿CASSETTE INSERTION/ PRESSURE OFF SET ERROR¿ WHEN USING THE PUMP TUBE SET. THE OPERATION HAD NOT BEGUN. THERE WAS NO HARM TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10073023 ↗
• MalfunctionAug 19, 2019Unintended Ejection; Unintended Ejection

  IT WAS REPORTED THAT IN THE MIDDLE OF AN UNKNOWN PROCEDURE, THE CASSETTE WAS SPONTANEOUSLY REMOVED FROM THE PUMP AT LEAST THREE TIMES. THIS CAUSED THE FLOW OF LIQUID TO THE JOINT TO BE RESTRICTED. TO CONTINUE WITH THE FLOW OF LIQUID TO THE JOINT, CONSTANT PRESSURE WAS APPLIED TO THE PUMP TO KEEP THE CASSETTE IN. A SURGICAL DELAY GREATER THAN 30 MINUTES WAS REPORTED. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE WITH NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8908177 ↗
• MalfunctionJul 6, 2018Leak/Splash; Pressure Problem

  IT WAS REPORTED THAT THE DEVICE HAD SOME ISSUES OF OVERPRESSURE, CAUSING LEAKING THAT SQUIRTED UP TO THE CEILING. THERE WAS NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7667200 ↗
• MalfunctionJun 11, 2018Pressure Problem

  IT WAS REPORTED THAT THE PRESSURE WAS SET ON "30" BUT AN OVERPRESSURE HAPPENED RESULTING IN EDEMA. THE WATER JET WAS EVEN OUTSIDE OF THE KNEE. THE PROCEDURE WAS INTERRUPTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7587422 ↗
• MalfunctionMar 1, 2018Break; Leak/Splash

  IT WAS REPORTED THAT THE CASSETTE STARTED TO LEAK INTO THE PUMP WHICH HAS ALSO CAUSED DAMAGE TO THE D25. NO PATIENT INJURY REPORTED. THE PROCEDURE WAS COMPLETED WITH A DEVICE FROM ANOTHER COMPANY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7307802 ↗