Kangaroo 673662Recalls & reported problems
Cardinal Health, Inc. · Epump Set with Flush Bag,Anti-free Flow · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Cardinal Health Kangaroo ePump feeding set has 123 adverse event reports, with no deaths or injuries. Most reports describe nutrition leaking at the bag or connections during priming or use, and some describe tubing coming apart or formula failing to flow. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 123
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 10884521028197), received between Apr 14, 2017 and Jun 24, 2021 — classified as 123 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (119 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak119
- Detachment of Device or Device Component22
- Occlusion Within Device2
- Air/Gas in Device1
- Disconnection1
- Obstruction of Flow1
Patient problems
- No Consequences Or Impact To Patient97
- No Clinical Signs, Symptoms or Conditions18
- No Patient Involvement5
- Insufficient Information2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 123 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT DURING PRIMING, WHEN THE BAG WAS FILLED WITH NUTRITION, THEY NOTED AN EXTERNAL LEAKAGE AT THE CONNECTION TUBE. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE REACTIONS WERE ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12058539 ↗MalfunctionJun 10, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THE FEEDING SET LEAKED BETWEEN THE BAG AND THE LINE. THE ISSUE OCCURRED DURING USE. THERE WAS PATIENT INVOLVEMENT; BUT NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE REACTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11974894 ↗MalfunctionMay 24, 2021Obstruction of Flow; Air/Gas in Device; Obstruction of Flow; Air/Gas in Device
THE CUSTOMER REPORTED THAT THE FORMULA WAS NOT PASSING THROUGH THE LINE AND WAS BUBBLING DESPITE PRIMING THE PUMP. WHEN USING ANOTHER BAG THERE WAS NO PROBLEM. PATIENT INJURY/HARM WAS REPORTED AS UNKNOWN. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT WHEN PRIMING THE PUMP AND PRESSING RUN, THE PUMP GAVE THE ERROR OF "FEEDING ERROR" AFTER A FEW MINUTES. WHEN CHECKING THE LINE, THERE WERE LARGE BUBBLES AND SPACES WHERE THE FORMULA WAS NOT FLOWING DESPITE NOT BEING OBSTRUCTED PER OBSERVATION. THE PUMP WAS RE-PRIMED AND WITHIN MINUTES GAVE THE ERROR AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11870438 ↗MalfunctionMay 18, 2021Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTS: DURING PRIMING, THE UNIT PRESENTED A NUTRITION LEAK AT THE BOTTOM OF THE DEVICE.
Patient problems: Insufficient Information
MAUDE report 11842750 ↗MalfunctionMay 18, 2021Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTS: DURING PRIMING, THE UNIT PRESENTED A NUTRITION LEAK AT THE BOTTOM.
Patient problems: Insufficient Information
MAUDE report 11842190 ↗MalfunctionMay 12, 2021Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTS: DURING USE THIS DEVICE WAS FILLED WITH INTESTINAL NUTRIENT WHICH WAS EXPECTED TO CONTINUE FOR 10 HOURS. ON THE SAME DAY, THE DEVICE'S PIPE CONNECTIONS HAD COME OFF, CAUSING A LARGE AMOUNT OF NUTRIENTS TO FLOW OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11815964 ↗MalfunctionApr 29, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEEDING SET PRESENTED A LEAKAGE BETWEEN THE BAG AND THE SET DURING USE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTIONS WERE ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11744896 ↗MalfunctionApr 13, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT WHEN THE FEEDING SET WAS HUNG ON THE INFUSION RACK, A LARGE AMOUNT OF NUTRITION LIQUID WAS FOUND LEAKING FROM THE PIPELINE. THERE WAS NO ADVERSE EVENT WITH THIS REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11656010 ↗MalfunctionApr 5, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THE CONNECTORS OF THE PRODUCTS ARE NOT COMPATIBLE WITH THE NASOGASTRIC FEEDING PUMP THE CUSTOMER IS USING. DUE TO THE CHANGE OF THE CONNECTORS THEY ARE EXPERIENCING THE PROBLEM OF FOOD DRIPPING INTO THE PATIENT'S BED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 5-APR-2021 STATES THAT THE NG TUBE THAT THE CUSTOMER USES IS A POLYURETHANE NUTRITION TUBE BY BEXEN MEDICAL. PRODUCT NUMBER: 054.08, LOT XS-1022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11616673 ↗MalfunctionFeb 12, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT PER DOCTOR, AFTER SWITCHING ON THE KANGAROO E-PUMP IN REGULAR FEED, MYSTIC JUNCTION WAS DISCONNECTING CONTINUOUSLY, AND FEED LEAKAGE WAS OBSERVED. THE CUSTOMER FURTHER STATED THAT THE TUBE IN THE BAG IS NARROW. AND THE BAG WAS CHOCKING DUE TO THIS. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE DIAMETER OF THE TUBING IS VERY NARROW, AND THE LINE APPEARS TO BE OCCLUDED. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11321247 ↗MalfunctionFeb 11, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT ACCORDING TO THE DOCTOR, AFTER SWITCHING ON THE KANGAROO EPUMP FOR REGULAR FEED, THE MISTIC JUNCTION DISCONNECTED AFTER 2-3 MINUTES. DUE TO THE DISCONNECTION THE FEED LEAKED. THIS WAS HAPPENING REPEATEDLY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11315864 ↗MalfunctionFeb 10, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
THE CUSTOMER REPORTED THERE WAS A DISCONNECTION OF THE TUBE AT THE MYSTIC JUNCTION CAUSING LEAKING. THIS WAS REPEATEDLY SEEN IN MULTIPLE BAGS FROM THE SAME BATCH FOR A HOME PATIENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11307806 ↗MalfunctionJan 29, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TUBING OF THE FEEDING SETS DETACHED DURING PATIENT FEEDING CAUSING THEM TO LEAK, IT WAS CONTINUOUSLY OOZING OUT EVEN ONCE IT WAS DETACHED FROM THE PATIENT UNTIL THE FEED WAS COMPLETELY STOPPED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11255016 ↗MalfunctionJan 29, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
THE CUSTOMER REPORTED THE TUBE DETACHED FROM THE CONNECTOR DURING OPERATION CAUSING A LEAK. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11253263 ↗MalfunctionJan 21, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE CONNECTOR OF THE PRODUCT IS NOT COMPATIBLE WITH THE NASOGASTRIC FEEDING TUBE THEY ARE USING. DUE TO THE PROBLEM WITH THE CONNECTORS, THEY ARE EXPERIENCING A PROBLEM OF FOOD DRIPPING ON THE PATIENT'S BED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11210731 ↗MalfunctionJan 15, 2021Fluid/Blood Leak; Detachment of Device or Device Component
THE CUSTOMER REPORTED THE HOSPITAL PURCHASED BOXES OF THE DUAL BAGS IN SEPTEMBER AND ALMOST EVERY DAY THE TUBE DISLODGES FROM THE CONNECTOR. ADDITIONAL INFORMATION RECEIVED STATED WHEN THE TUBE DETACHES, THE FORMULA LEAKS FROM THE SET. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11177279 ↗MalfunctionJan 15, 2021Fluid/Blood Leak; Detachment of Device or Device Component
THE CUSTOMER REPORTED THE HOSPITAL PURCHASED THE DUAL BAGS IN SEPTEMBER AND ALMOST EVERY DAY THE TUBE DISLODGES FROM THE CONNECTOR. ADDITIONAL INFORMATION RECEIVED STATED WHEN THE TUBE DETACHES, THE FORMULA LEAKS FROM THE SET. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11177116 ↗MalfunctionJan 11, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE STAFF NURSE WAS TRYING TO CONNECT A NEW FEEDING BAG TO THE EPUMP FOR TESTING. HOWEVER, THE MOMENT THE EPUMP WAS RAN, THE SILICONE TUBE DISLODGED FROM THE CONNECTOR. THE CUSTOMER FURTHER STATED THEY HAVE USED THE EPUMP FOR MANY YEARS AND THE UNITS ARE SERVICED UP TO DATE. THE TUBE DISLODGED EASILY AND WAS NOT AS TIGHT AS IT HAS BEEN IN THE PAST. ADDITIONAL INFORMATION PROVIDED STATED THAT THE CONNECTOR SIDE WITH THE BLACK RING DISCONNECTED FROM THE CREAM COLORED TUBING. A PHOTO WAS PROVIDED AND SHOWED THAT THE FEEDING SET LEAKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11148282 ↗MalfunctionJan 11, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE STAFF NURSE WAS TRYING TO CONNECT NEW FEEDING BAGS TO THE EPUMP FOR TESTING. HOWEVER, THE MOMENT THE EPUMP WAS RAN, THE SILICONE TUBE DISLODGED FROM THE CONNECTORS. THE CUSTOMER FURTHER STATED THAT THEY HAVE USED THE EPUMP FOR MANY YEARS AND THE UNITS ARE SERVICED UP TO DATE. THE TUBES DISLODGED EASILY AND WERE NOT AS TIGHT AS THEY HAVE BEEN IN THE PAST. ADDITIONAL INFORMATION PROVIDED STATED THAT THE CONNECTOR SIDE WITH THE BLACK RINGS DISCONNECTED FROM THE CREAM COLORED TUBINGS. A PHOTO WAS PROVIDED AND SHOWED THAT THE FEEDING SETS LEAKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11148193 ↗MalfunctionJan 5, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THERE IS A CRACK ALONG THE TUBING WHICH CAUSED THE FEEDING TO LEAK. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11120930 ↗MalfunctionDec 2, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TUBING DISCONNECTED AUTOMATICALLY AND LEAKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10936518 ↗MalfunctionDec 2, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TUBING DISCONNECTED AUTOMATICALLY AND LEAKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10936416 ↗MalfunctionDec 2, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TUBING DISCONNECTED AUTOMATICALLY AND LEAKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10936259 ↗MalfunctionDec 2, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TUBING DISCONNECTED AUTOMATICALLY AND LEAKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10936204 ↗MalfunctionDec 2, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TUBING DISCONNECTED AUTOMATICALLY AND LEAKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10936031 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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