Kangaroo 673656Recalls & reported problems
Cardinal Health, Inc. · Epump Set,Anti-free Flow · Class 2
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521028166), received between Jan 9, 2018 and Aug 23, 2021 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (7 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
- Air/Gas in Device7
- Fluid/Blood Leak4
- Detachment Of Device Component1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT WHEN STARTING THE INFUSION OF FOOD, LEAKAGE IS OBSERVED THROUGH THE CONNECTION VALVE. A CHANGE OF MEDICAL DEVICE WAS MADE. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12353222 ↗MalfunctionJul 30, 2021Air/Gas in Device; Air/Gas in Device
THE CUSTOMER, WHO IS A HEALTH CARE PROFESSIONAL, REPORTED THAT THE HOME PATIENT EXPERIENCED AIR IN THE LINE WITH MULTIPLE FEEDING SETS FROM THE SAME BOX. THERE WERE NO INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12256263 ↗MalfunctionJul 30, 2021Air/Gas in Device; Air/Gas in Device
THE CUSTOMER, WHO IS A HEALTH CARE PROFESSIONAL, REPORTED THAT THE HOME PATIENT EXPERIENCED AIR IN THE LINE WITH MULTIPLE FEEDING SETS FROM THE SAME BOX. THERE WERE NO INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12256244 ↗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 11870205 ↗MalfunctionMay 13, 2021Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED THE INSIDE OF THE TUBE CONTAINED A LARGE AMOUNT OF AIR BUBBLES DURING THE FEEDING. NO PATIENT INJURY OR ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11816575 ↗MalfunctionMay 13, 2021Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED THE INSIDE OF THE TUBE CONTAINED A LARGE AMOUNT OF AIR BUBBLES DURING THE FEEDING. NO PATIENT INJURY OR ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11816543 ↗MalfunctionMay 13, 2021Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED THE INSIDE OF THE TUBE CONTAINED A LARGE AMOUNT OF AIR BUBBLES DURING THE FEEDING. NO PATIENT INJURY OR ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11816538 ↗MalfunctionMay 13, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT WHEN THE NURSE STARTED THE FEEDING, THE FEEDING BAG STARTED TO LEAK IN BETWEEN THE TUBING THAT DIRECTLY CONNECTED TO THE FEEDING BAG. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11816499 ↗MalfunctionApr 29, 2021Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED THE INSIDE THE TUBE CONTAINED A LARGE AMOUNT OF AIR BUBBLES DURING THE FEEDING. NO PATIENT INJURY OR ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11750264 ↗MalfunctionDec 8, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE BAG WAS TORN BY THE MEMBRANE, WHEN THE FEEDING PROCESS WAS CARRIED OUT. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE BAG WAS LEAKING. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10972229 ↗MalfunctionSep 28, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEED HAD LEAKED FROM THE CONNECTOR OF THE ENTERAL FEEDING SET. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10593467 ↗MalfunctionJan 9, 2018Detachment Of Device Component; Detachment Of Device Component
THE CUSTOMER REPORTED DURING USE OF THE TUBING CAME OUT FROM THE PUMP, AND THE PIECES DIDN¿T STAY TOGETHER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7176918 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.