Nexus TKO® N3561Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10815879020731), received between Feb 6, 2018 and Nov 26, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 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.

• MalfunctionNov 26, 2019Crack; Leak/Splash

  IV TUBING INFUSING DRIPS FOR PATIENT. WENT TO ASSESS PATIENT AND FOUND THE DEVICE TO BE CRACKED AND LEAKING FLUIDS WHERE THE MANIFOLD ATTACHES TO THE CAP OF PATIENT'S CENTRAL LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9375378 ↗
• MalfunctionNov 22, 2019Break; Material Separation

  IV FLUIDS, VERSED, FENTANYL AND VECURONIUM DRIPS INFUSING VIA MANIFOLD INTO PATIENTS CENTRAL LINE. PLASTIC END PIECE OF MANIFOLD FOUND LYING IN BED BROKEN INTO SEVERAL PIECES. IV FLUIDS AND DRIPS INFUSING INTO THE PATIENT'S BED. SUBSEQUENTLY, INFORMED OF ANOTHER MANIFOLD THAT FELL APART DURING USE BUT THIS ONE WAS NOT SAVED.

  Patient problems: Missed Dose

  MAUDE report 9362318 ↗
• MalfunctionFeb 6, 2018Fluid/Blood Leak

  MANIFOLD LEAKED AND SOAKED THE BED AFTER REPLACING. PREVIOUS MANIFOLD DID NOT LEAK AND WHEN REPLACED THIS NEXT MANIFOLD DID NOT LEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7243797 ↗
• MalfunctionFeb 6, 2018Connection Problem; Device Dislodged or Dislocated; Improper Flow or Infusion

  IV MANIFOLD BROKE WHILE DISCONNECTING MANIFOLD FROM PORT TUBING TO DRAW BLOOD CULTURES. THE ROUND PORTION OF THE MANIFOLD THAT SCREWS INTO THE PORTS TUBING POPPED OFF OF THE REST OF THE MANIFOLD, MAKING IT IMPOSSIBLE TO HOOK THE MANIFOLD BACK UP TO THE PORT TUBING. IN ORDER TO REPLACE THE MANIFOLD, THE NEW MANIFOLD HAD TO BE FLUSHED WITH SALINE. THUS IT TOOK A WHILE FOR THE DRIPS THAT HAD BEEN INFUSING IN THE MANIFOLD (FENTANYL, VERSED, AND EPINEPHRINE) TO REACH THE PATIENT. RESIDENT AND CHARGE RN WERE NOTIFIED OF RESULTING DECREASE IN MEAN ARTERIAL PRESSURES (MAPS) DUE TO DELAY IN EPINEPHRINE REACHING THE PATIENT. PT REMAINED STABLE, MAPS RETURNED TO WITHIN DEFINED LIMITS AFTER ~15 MINUTES OF INFUSION THROUGH THE NEW MANIFOLD. DAMAGED MANIFOLD PUT IN PLASTIC BAGGIE AND LEFT IN SUPERVISOR'S MAILBOX FOR VIEWING.

  Patient problems: Low Pulmonary Arterial Wedge Pressure

  MAUDE report 7243767 ↗