Kangaroo 772055 (UDI 10884521023925)Recalls & reported problems
Cardinal Health, Inc. · Epump Set,Anti-free Flow · Class 2
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884521023925), received between Jun 27, 2017 and Jan 24, 2022 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 Leak9
- Air/Gas in Device6
- Infusion or Flow Problem3
- Detachment of Device or Device Component1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Consequences Or Impact To Patient8
- Insufficient Information2
- Constipation1
- No Known Impact Or Consequence To Patient1
- Vomiting1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2022Infusion or Flow Problem; Infusion or Flow Problem
THE CUSTOMER REPORTED AIR SPACE IN THE FEEDING SET SECTION BETWEEN THE PUMP AND THE PATIENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13333248 ↗MalfunctionJan 24, 2022Infusion or Flow Problem; Infusion or Flow Problem
THE CUSTOMER REPORTED AIR SPACE IN THE FEEDING SET SECTION BETWEEN THE PUMP AND THE PATIENT. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13333202 ↗MalfunctionNov 4, 2021Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED THEY ARE HAVING PROBLEMS WITH THE LAST BATCH OF TUBE FEED BAGS. THEY HAVE AIR POCKETS IN THE LINES, FINISH BEFORE THEY ARE EMPTY AND WON'T DRAIN FOR CLEANING SOMETIMES. ONE OF THEM HAD A SMALL HOLE THAT ALLOWED AIR INTO THE BAG WHILE CLOSED. ADDITIONAL INFORMATION RECEIVED STATED THAT VARIOUS STAFF MEMBERS FOR THE ONE CLIENT STATED THAT THEY FOUND PIN SIZED HOLES BOTH IN THE TUBE FEED BAG AND THE LINE. SHE BELIEVES IT HAPPENED WITH 5 OR LESS OF THE BAGS FROM THIS LOT. DURING THIS PROCESS THEY HAVE ALSO RECEIVED A NEW JOEY PUMP WHICH HAS HELPED WITH SOME OF THE PROBLEMS; HOWEVER, IT HAS NOT RESOLVED THE ISSUES COMPLETELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12751772 ↗MalfunctionJun 14, 2021Air/Gas in Device; Air/Gas in Device
CUSTOMER REPORTS: AIR ENTERED INTO THE TUBING.
Patient problems: Insufficient Information
MAUDE report 11991756 ↗MalfunctionApr 28, 2021Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED THAT HER SON EXPERIENCED QUITE A BIT OF VOMITING WHILE USING THE ENTERAL FEEDING SET. THERE WOULD BE WEEKS WHERE HE WOULD THROW UP AT LEAST ONCE A DAY. THIS WAS A HUGE ISSUE WITH HIM GAINING WEIGHT AS HE RECEIVES ALL HIS DAILY NUTRITION THROUGH A G-TUBE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT AIR WAS GETTING IN THE FEEDING TUBE LINE DURING FEEDS. THEY ADJUSTED THE FEED RATES, TIMING, VOLUME, AND FORMULAS. HIS VOMITING WAS UNPREDICTABLE. THE CUSTOMER FURTHER STATED HER SON HAD SOME BAD CONSTIPATION DURING THIS TIME AS WELL. HE WAS PRESCRIBED (B)(6) FOR THE CONSTIPATION.
Patient problems: Constipation; Vomiting
MAUDE report 11740522 ↗MalfunctionMar 11, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE ENTERAL FEEDING SET BAG HAD A HOLE AND LEAKED WHERE THE BAG ATTACHES TO THE TUBING AND THIS AFFECTED THE FEEDING OF THE NEONATAL PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11467944 ↗MalfunctionDec 31, 2020Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED THAT THE FEEDING SET HAD LONG GAPS OF AIR IN THE TUBING LINE BETWEEN THE FORMULA. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11102129 ↗MalfunctionDec 30, 2020Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED THAT THERE WAS AIR IN THE TUBING OF THE FEEDING SET. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11095919 ↗MalfunctionDec 23, 2020Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED THAT THERE WAS AIR IN TUBING WHEN FEEDING THE PATIENT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11065935 ↗MalfunctionDec 15, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEEDING BAG LEAKING FROM THE BOTTOM. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11008322 ↗MalfunctionNov 17, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THERE WAS WASTED MILK DURING PRIMING PROCESS BEFORE FEEDING. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON (B)(6) 2020 STATED THAT THE RN WAS PRIMING THE BAG WITH THE PATIENT'S MILK AND NOTICED LEAKING FROM THE BOTTOM POUCH OF THE BAG. THEY WERE UNABLE TO CONTINUE TO PRIME AND USE THE SET. A NEW PACKAGE WAS OPENED BY THE CLINICIAN TO CONTINUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10853565 ↗MalfunctionNov 12, 2020Infusion or Flow Problem; Infusion or Flow Problem
THE CUSTOMER REPORTED THERE ARE LARGE AIR POCKETS AS THE FORMULA IS PUSHED THROUGH THE LINE. THIS HAPPENS A COUPLE HOURS AFTER THE LINE HAS ALREADY BEEN PRIMED. THEY HAVE CHANGED THE TUBING AND THE PUMP BUT IT STILL HAS LARGE AIR POCKETS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10828590 ↗MalfunctionAug 31, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER STATES THE SET IS LEAKING AT THE CONNECTION OF THE TUBING AND CASSETTE WHERE THE TUBING SITS IN THE PUMP. THE CUSTOMER FURTHER STATED THAT THE PUMP ALSO ACTS LIKE IT IS INFUSING FORMULA, HOWEVER, NOTHING IS ACTUALLY INFUSING, THEN IT ALARMS OCCLUSION AFTER 4-5CC.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10472375 ↗MalfunctionAug 31, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER STATES THE SET IS LEAKING AT THE CONNECTION OF THE TUBING AND CASSETTE WHERE THE TUBING SITS IN THE PUMP. THE CUSTOMER FURTHER STATED THAT THE PUMP WILL ALSO ACT LIKE IT IS INFUSING FORMULA, HOWEVER, NOTHING IS ACTUALLY INFUSING, THEN IT ALARMS OCCLUSION AFTER 4-5CC.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10472047 ↗MalfunctionAug 28, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT AT APPROXIMATELY 0205 IN THE MORNING, THE NURSE WENT TO POUR A FEED INTO THE 500ML BAG. THE NURSE THOUGHT SHE MISSED AS THE FORMULA LEAKED ALL OVER. THE NURSE LOOKED AND NOTICED THAT THE BAG ITSELF WAS LEAKING FROM THE DISTAL END OF THE BAG, YET THE PROXIMAL HEAD OF THE TUBING. ABOUT 50ML OF FORMULA WAS LOST/WASTED. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10468667 ↗MalfunctionAug 25, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER STATES THAT THE SETS ARE LEAKING AT THE CONNECTION OF THE TUBING AND CASSETTE WHERE THE TUBING SITS IN THE PUMP. THE CUSTOMER FURTHER STATED THAT THE PUMP WILL TRY INFUSING FORMULA, HOWEVER, NOTHING INFUSES, THEN IT ALARMS OCCLUSION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10447827 ↗MalfunctionJul 24, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE ENTERAL FEEDING SET WAS LEAKING. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10323780 ↗MalfunctionMay 21, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTS THAT THE FORMULA WAS SEEPING THROUGH THE TUBING THAT GOES TO THE PUMP. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8627779 ↗MalfunctionJun 27, 2017Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT WHILE IN USE WITH A PATIENT, THE NURSE CLAMPED THE TUBING AND THE MEDICINE WAS PUSHED THROUGH THE SIDE PORT WHEN THE NURSE HEARD POP NOISE IN THE PUMP. THE CUSTOMER FOUND THAT THE FLEXIBLE PORTION OF THE FEEDING TUBE HAD DETACHED AND STARTED LEAKING FORMULA. NO PATIENT INJURY OR HARM REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6670048 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.