Kangaroo 461255E (UDI 20884521742236)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20884521742236), received between Jul 15, 2019 and May 26, 2023 — classified as 1 death, 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE IRIS PURPLE HUB AT THE END BECAME SEPARATED COMPLETELY FROM THE Y PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17013107 ↗
• DeathNov 17, 2022Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THE RRT NURSE ARRIVED AT 0530 WITH A NURSE THEY WERE TRAINING AND REPLACED THE IRIS FEEDING TUBE ON THE FIRST ATTEMPT (MODEL 461255E). AT 0623 THE RADIOLOGIST NOTIFIED THE DCN THAT THE FEEDING TUBE WAS WITHIN THE LEFT LOWER LOBE OF THE LUNG. THE DCN PAGED RRT NURSE AND COMMUNICATED THE FINDINGS. THE RRT NURSE RETURNED AND REMOVED THE IRIS FEEDING TUBE. MULTIPLE ATTEMPTS WERE THEN MADE TO REPLACE IT WITH A NEW ONE (MODEL 461255E). THE PATIENT BEGAN TO DECOMPENSATE WITH INCREASED END TIDAL CO2 READINGS INTO THE 80¿S, OXYGEN SATURATION READINGS INTO THE 80¿S, AND LOWER TIDAL VOLUMES. RESPIRATORY THERAPY WAS PAGED AND ARRIVED TO ASSIST THE PATIENT IN RECOVERY. THE DECISION WAS MADE TO STOP THE INSERTION AT THAT TIME, THE IRIS FEEDING TUBE WAS REMOVED, AND THE RRT NURSE LEFT. MINUTES LATER THE OXYGEN SATURATIONS BEGAN TO DROP AGAIN INTO THE 70¿S. THE RRT NURSE WAS CALLED AGAIN TO RETURN TO THE ROOM AT 0657. PRIOR TO LEAVING THE CRITICAL CARE UNIT, THE RRT NURSE LET THE INTENSIVIST KNOW THE PAGE WAS FOR A PATIENT WHO HAD JUST HAD A MALPOSITIONED IRIS FEEDING TUBE REMOVED. THE PATIENT THEN LOST HER PULSE, AND A CODE BLUE WAS CALLED AT 0706. ALL ACLS PROTOCOLS WERE FO

  Patient problems: Low Oxygen Saturation; Pneumothorax

  MAUDE report 15815325 ↗
• MalfunctionJul 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PATIENT WAS TRANSFERRED FROM ANOTHER UNIT RIGHT AT SHIFT CHANGE. THE PATIENT HAD A DOBHOFF FEEDING TUBE WITH IRIS THAT WAS BROKEN AT THE CONNECTING Y SITE. THE NURSE WAS UNABLE TO ADMINISTER MEDICATION OR TUBE FEED WITHOUT IT LEAKING OUT OF THE OTHER SITE. THE PATIENT TUBE FEEDS WERE POSTPONED UNTIL A NEW ONE WAS PLACED. THE BROKEN FEEDING TUBE WAS DISCARDED. THE TUBE HAD BEEN IN PLACE FOR 16 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15027082 ↗
• MalfunctionAug 23, 2021Break; Break

  THE CUSTOMER REPORTED FULL DEGRADATION OF MATERIAL AT THE DISTAL TIP OF THE IRIS FEEDING TUBE, IN BETWEEN EYELETS AND CAMERA, EXPOSING WIRING CONNECTED TO THE CAMERA WHILE INDWELLING IN PATIENT. THE PRODUCT WAS VISIBLY NOTICED UPON REMOVAL OF THE FEEDING TUBE FROM THE PATIENT. THE IRIS FEEDING TUBE WAS INITIALLY INSERTED ON (B)(6) 2021 AND REMOVED ON (B)(6) 2021, INDWELLING FOR 14 DAYS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021 STATED THAT THERE WAS VISIBLE COILING OF THE FEEDING TUBE IN THE STOMACH PER X-RAY IMAGING. THIS PROMPTED A RE-CONNECTION OF THE IRIS FEEDING TUBE TO THE CONSOLE IN ATTEMPT TO RE-PLACE IN THE EXPECTED LOCATION OF THE SMALL BOWEL. THE FEEDING TUBE WAS RECONNECTED TO THE IRIS CONSOLE WHILE STILL INDWELLING. THE CONSOLE IMAGING WAS NOT CLEAR, OTHER THAN WHAT APPEARED TO BE ORANGE COLORED BILE ENCOMPASSING THE IRIS CONSOLE SCREEN. THE FEEDING TUBE WAS RETRACTED IN AN ATTEMPT TO UNCOIL AND SUBSEQUENTLY TOTALLY REMOVED FROM PATIENT. SLIGHT RESISTANCE WAS MET WHEN PULLING THE DISTAL END OF THE IRIS TUBE OUT OF THE NARE UPON REMOVAL. AT THE POINT OF REMOVAL IS WHEN THE REPORTED ISSUE WAS CLEARLY VISIBLE. NO KNOWN INJURY OR MEDICAL INTERVENTION TO THE PATIENT BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354340 ↗
• MalfunctionFeb 22, 2021Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE SMALL BORE FEEDING TUBE CRACKED AT THE TOP PLASTIC PART. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT IT WAS THE Y-PORT THAT CRACKED, IT CRACKED ALL THE WAY THROUGH AND BECAME DETACHED DURING USE CAUSING THE TUBE FEEDING TO LEAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11361153 ↗
• InjuryDec 8, 2020Obstruction of Flow; Separation Failure; Obstruction of Flow; Separation Failure

  THE CUSTOMER REPORTED THAT IN THE EARLY MORNING, THEY WENT IN TO GIVE THE PATIENT SOME MEDS VIA NASOJEJUNAL TUBE. FLUSHED TUBE WITH 30 ML. THEN AS SOON AS THEY WENT TO GIVE MEDS, CRUSHED AND MIXED WELL WITH ABOUT 40ML OF WATER, THE TUBE IMMEDIATELY CLOGGED. IT WAS THEN NOTICED THAT THE TUBE STILL HAD THE GUIDE WIRE IN THE TUBE. IT IS UNCLEAR WHY THE GUIDE WIRE WAS LEFT IN TUBE EVEN AFTER PLACEMENT WAS VERIFIED AND TUBE FEEDINGS WERE STARTED. WHATEVER THEY TRIED, THE TUBE WOULD NOT UNCLOG. THEY ATTEMPTED TO REMOVE THE WIRE AND IT WOULD ONLY COME OUT PART WAY AND THEN THE TUBE WOULD COIL AND IRRITATED AND CAUSED PAIN FOR PATIENT. TEAM NOTIFIED; KEOFEED REPLACED ENDOSCOPICALLY UNDER GENERAL ANESTHESIA. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON DECEMBER 14, 2020 STATED THAT THE RN UTILIZED THE KEOFEED WITH THE GUIDEWIRE IN PLACE BECAUSE SHE ASSUMED THAT THE CORRECT PORT WAS VISIBLE AND SHE LACKED THE KNOWLEDGE OF THE PRODUCT WHICH WAS NEW TO THEM. IT IS UNKNOWN IF THERE WERE ANY KINKS IN THE TUBING. THE PATIENT REQUIRED THE ANESTHESIA TO REPLACE THE KEOFEED AND HAD TO HAVE AN ENDOSCOPY TO HAVE THE KEOFEED REMOVED AND HAVE A PEG PLACED. THE KEOFEED COULD NOT BE PLACED AT BEDSI

  Patient problems: Pain

  MAUDE report 10972107 ↗
• MalfunctionJul 15, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTS THE KANGAROO TUBE CRACKED IN 2-3 DIFFERENT PLACES AT THE CONNECTION PORTS, AND LEAKED WHEN THE FLUID WAS BEING INFUSED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8789592 ↗