Kangaroo 762055Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10884521072299), received between Jun 21, 2017 and Mar 8, 2023 — classified as 2 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (21 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

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2023Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THAT THE TUBING WAS SHORTER THAN USUAL, AND IT WAS CREATING BUBBLES IN THE TUBE WHEN THEY WERE ADDING THE LIQUID IN THE TUBE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PATIENT TRIED THE BAGS, AND EACH BAG THEY TRIED WERE LEAKING FORMULA ALL OVER THE PUMP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16503748 ↗
• InjuryDec 12, 2022Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED AN ISSUE WITH AN UNKNOWN ENTERAL FEEDING PUMP SET WHERE IT CAUSED HER SON HOSPITALIZED AT LEAST 5 TIMES FOR VOMITING, HUGE, BLOATED STOMACH, AND SEVERE ABDOMINAL PAIN. THE CUSTOMER STATED THAT SHE IS DOING A 24/7 CARE TO HER SON WHO IS IN TOTAL CARE (INTENSIVE). PER CUSTOMER, SHE HAS NUMEROUS FEED PUMPS AND FEED BAGS DUE TO HER SON¿S CARE FOR THE PAST 24 YEARS. SHE TOOK HIM OFF THE FEED PUMPS AND NOW SHE IS USING GRAVITY FEED BAGS FOR HIS SON DUE TO NUMEROUS HOSPITALIZATIONS DUE TO THIS PROBLEM. ON MARCH 1, 2021, CARDINAL HEALTH SENT OUT A MEDICAL DEVICE CORRECTION LETTER REGARDING THE KANGAROO ENTERAL FEED PUMPING SETS. THE PURPOSE OF THIS COMMUNICATION WAS TO ADVISE CUSTOMERS OF THE POTENTIAL FOR AIR APPEARING IN THE ENTERAL FEED PUMPING SET TUBING DURING SET-UP. ALTHOUGH THERE WAS LIMITED INFORMATION PROVIDED BY THE CUSTOMER REGARDING THE SPECIFIC ISSUE RELATING TO THE PUMP / PUMP SET, THIS COMPLAINT WILL BE FILED AS THE REPORTABLE MALFUNCTION OF AIR IN THE LINE WITH A PUMP SET SINCE IT WAS IN RESPONSE TO THE COMMUNICATION SENT OUT TO CUSTOMERS REGARDING THIS ISSUE WITH THE KANGAROO ENTERAL FEEDING PUMP SETS. SEVERAL ATTEMPTS TO GATHER INFORMATION FROM THE

  Patient problems: Abdominal Distention; Abdominal Pain; Vomiting

  MAUDE report 15960700 ↗
• MalfunctionSep 24, 2021Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THERE ARE AIR GAPS IN THE FEEDING SET GREATER THAN 2.5CM. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530226 ↗
• MalfunctionSep 24, 2021Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THERE ARE AIR GAPS IN THE FEEDING SET GREATER THAN 2.5CM. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530174 ↗
• MalfunctionSep 22, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED THE CLIENT HAS BEEN OBSERVING AIR IN THE LINE GREATER THAN 1 INCH. THE PROBLEM HAS BEEN CONSISTENT WITH THE CASE SHE IS CURRENTLY USING WITH MANY OF THE BAGS NOT USABLE. THIS CLIENT IS VERY FAMILIAR WITH THE PRODUCT AND HAS BEEN USING IT FOR MANY YEARS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512908 ↗
• MalfunctionSep 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT REGISTERED NURSE (RN) HAD ADMINISTERED MEDICATIONS THROUGH A NASOJEJUNAL TUBE (FLUSHED APPROPRIATELY) AND RESTARTED FEEDS. THE PUMP BEGAN RINGING ¿OCCLUDED DOWNSTREAM¿. THE FEED WAS PAUSED, AND NJ TUBE FLUSHED WITH NO RESISTANCE. ON INSPECTION OF FEEDING BAG/PUMP, THE CASSETTE WAS NOTED TO BE LEAKING. THE BAG WAS REPLACED WITH A NEW FEEDING SET AND NO FURTHER ISSUES WERE NOTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE LINE WAS NOT OCCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12420937 ↗
• MalfunctionAug 18, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE KANGAROO JOEY PUMP SET TUBING DISLODGED FROM THE ANTI-FREE FLOW ATTACHMENT OF THE TUBING WHILE IN A KANGAROO PUMP. ADDITIONAL INFORMATION RECEIVED STATED A FEW DROPS WERE NOTED AT THE MOMENT THAT THE TUBING DISLODGED FROM THE PUMP, HOWEVER, THE FORMULA DID NOT ALL LEAK FROM THE TUBING WHEN IT WAS DISLODGED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337817 ↗
• MalfunctionJun 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE JOEY FEED PUMP WAS RINGING OFF OCCLUSION. THE TUBE WAS CHECKED FOR POTENCY AND THEN THE FEEDLINE LINE WAS RE-STARTED. ONCE RE-STARTED, THE FEED LINE SNAPPED AND SPRAYED FORMULA INTO NURSE¿S FACE. THE PUMP AND THE BAG WERE CHANGED WITH NO OTHER ISSUES. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995547 ↗
• MalfunctionMay 25, 2021Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER WHO IS A HEALTHCARE PROFESSIONAL, REPORTED THAT THE PARENTS OF A CHILD NOTICED AIR IN THE FEEDING LINE OF THE ENTERAL PUMP SET DURING USE. THE AIR BUBBLE WAS REPORTED TO BE OVER 10CM IN LENGTH. THERE WAS NO REPORT OF MEDICAL ATTENTION BEING REQUIRED. THE FEEDING SET WAS REPLACED WITH ANOTHER AND THE ENTERAL PUMP USE RESUMED. THE REPORTER STATED THAT THE PARENT OF THE PATIENT INVOLVED MENTIONED THAT THE PATIENT MAY HAVE BEEN UNSETTLED, POSSIBLY RELATED TO THE PRODUCT ISSUE, BUT THIS CANNOT BE CONFIRMED. PER THE HEALTHCARE PROFESSIONAL, THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Malaise

  MAUDE report 11878310 ↗
• MalfunctionApr 5, 2021Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THAT MORE THAN HALF OF THE CASE HAS HAD AN EXCESS OF AIR IN THE TUBING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11616699 ↗
• MalfunctionMar 29, 2021Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THAT THE TUBING WAS BUBBLING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581141 ↗
• MalfunctionMar 26, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED AIR IS APPEARING IN THE TUBING BETWEEN THE PUMP AND THE PATIENT. THE FEEDING SET IS NOT LEAKING. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11578458 ↗
• MalfunctionFeb 19, 2021Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THAT AN AIR IN THE TUBING SECTION WAS OBSERVED BETWEEN THE PUMP AND THE PATIENT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11349050 ↗
• MalfunctionJan 20, 2021Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THAT LARGE AIR BUBBLES WAS NOTICED IN TUBING BETWEEN THE PUMP AND THE PATIENT DURING FEEDING. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11203415 ↗
• MalfunctionDec 29, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED AIR IS GETTING IN THE TUBING OF THE FEEDING SETS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089918 ↗
• MalfunctionDec 22, 2020Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THAT THEY HAD NOTICED LARGE AIR POCKETS THROUGHOUT THE TUBING. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11056607 ↗
• InjuryDec 17, 2020Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED AIR SPACING (6-8 INCHES IN LENGTH) APPEARING IN THE ENTERAL FEEDING SET TUBING BETWEEN THE PUMP AND THE (B)(6) YEAR OLD MALE PATIENT WHO SUFFERS FROM LEUKODYSTROPHY. THE ACCUMULATION OF AIR IN THE STOMACH CAUSED THE PATIENT TO VOMIT WHICH IN TURN TRIGGERED AN EPILEPTIC SEIZURE. THE ISSUE STARTED WHEN THEY OPENED A NEW CASE OF ITEM 762055, LOT# 201600024 ON (B)(6) 2020 AND USED FIVE SETS SINCE THEN. THE PUMP DID NOT ALARM BECAUSE THE AIR WAS IN THE TUBING BETWEEN THE PUMP AND THE PATIENT. THE PATIENT IS FED AT 45ML/HR WITH A VOLUME OF 750ML. FEEDING STARTS AT 8AM AND ENDS AT 2AM THE FOLLOWING MORNING. FEEDINGS HAVE TO BE DONE 250ML AT A TIME BECAUSE THE FOOD HAS TO BE ADMINISTERED WHILE STILL COLD BECAUSE OF THE PATIENT'S CONDITION. LENGTH OF FEEDING IS APPROXIMATELY 18HRS. THE PATIENT WAS NOT OVER FED OR UNDER FED BUT THE FEEDINGS WERE DELAYED WHEN THEY HAD TO CHANGE THE SETS EVERY TIME. THEY NORMALLY CHANGE THE SETS EVERY THREE DAYS. THE PATIENT HAS A G-TUBE FOR DELIVERY. ADDITIONAL INFORMATION PROVIDED ON 10-DEC-2020 STATED THAT THE PATIENT HAS A HISTORY OF SEIZURES DUE TO HIS RARE DISEASE. VOMITING DOES HAPPEN EVERY NOW AND THEN WITH THE PATIENT'S CONDITION

  Patient problems: Convulsion/Seizure; Vomiting

  MAUDE report 11033331 ↗
• MalfunctionDec 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT BETWEEN (B)(6) 2020 AND (B)(6) 2020 SHE EXPERIENCED 9 FEEDING SETS THAT LEAKED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11011488 ↗
• MalfunctionDec 15, 2020Air/Gas in Device; Air/Gas in Device

  THE WIFE OF THE HOME PATIENT REPORTED THAT THERE WAS AIR IN THE LINE WHILE USING THE FEEDING SET. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11006301 ↗
• MalfunctionDec 10, 2020Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THAT THERE WERE LARGE POCKETS OF AIR IN THE TUBING AROUND PUMP'S ROTOR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10983937 ↗
• MalfunctionDec 9, 2020Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED THAT AIR WAS ACCUMULATING IN THE TUBING (AIR SPACE IS BETWEEN 6 TO 8 INCHES). THE PATIENT FED THREE TIMES A DAY: 1ST FEED WAS 80ML/HOUR FROM 6 AM TO 11 AM 500ML VOLUME; SECOND FEED WAS 100ML/HOUR FROM 12PM TO 6PM (FEED N FLUSH) 500ML VOLUME PLUS 100ML WATER; THIRD FEED WAS 80ML/HOUR FROM 9PM TO 4AM. THE LENGTH OF THE FEED HAS NOT CHANGED WHILE HAVING ISSUES. THE CUSTOMER FURTHER STATED THAT THEY ARE USING A ¿G-TUBE¿ DELIVERY AND THE PUMP SET WAS CHANGED EVERY 2 WEEKS. THE ISSUE WAS DISCOVERED DURING USE. NO ERROR MESSAGE WAS APPEARED ON THE PUMP. THE PATIENT WAS NOT OVERFED OR UNDERFED DURING THE INCIDENT. THE PATIENT FELT DISCOMFORT DUE TO AIR GOING INTO THE STOMACH.

  Patient problems: Discomfort

  MAUDE report 10975408 ↗
• MalfunctionDec 3, 2020Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED THAT AIR WAS ACCUMULATING IN THE TUBING (AIR SPACE IS BETWEEN 6 TO 8 INCHES). THE PATIENT FED THREE TIMES A DAY: 1ST FEED WAS 80ML/HOUR FROM 6AM TO 11AM 500ML VOLUME; SECOND FEED WAS 100ML/HOUR FROM 12PM TO 6PM (FEED N FLUSH) 500ML VOLUME PLUS 100ML WATER; THIRD FEED WAS 80ML/HOUR FROM 9PM TO 4AM. THE LENGTH OF THE FEED HAS NOT CHANGED WHILE HAVING ISSUES. THE CUSTOMER FURTHER STATED THAT THEY ARE USING A "G-TUBE" DELIVERY AND THE PUMP SET WAS CHANGED EVERY 2 WEEKS. THE ISSUE WAS DISCOVERED DURING USE. NO ERROR MESSAGE WAS APPEARED ON THE PUMP. THE PATIENT WAS NOT OVERFED OR UNDERFED DURING THE INCIDENT. THE PATIENT FELT DISCOMFORT DUE TO AIR GOING INTO THE STOMACH.

  Patient problems: Discomfort

  MAUDE report 10942874 ↗
• MalfunctionNov 25, 2020Fluid/Blood Leak; Infusion or Flow Problem; Fluid/Blood Leak; Infusion or Flow Problem

  THE CUSTOMER REPORTED THAT THERE WERE BIG BUBBLES CAUSED BY THE FEED BAGS. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON (B)(6) 2020 STATED THAT IT LOOKS LIKE THE SETS ARE LEAKING AT THE VALVE OF THE PUMP SET SINCE THAT APPEARS TO BE WHERE THE BUBBLES ARE ORIGINATING AND THEY ARE SEEING WETNESS AROUND THE VALVE STEM SOMETIMES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10904407 ↗
• MalfunctionNov 13, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED 10 OF THE PUMP SETS HAVE BEEN DRAWING AIR INTO TUBING IN 6 TO 12 INCH LENGTHS OF AIR. FORMULA WAS FOLLOWING THE BAG WITHOUT ISSUE, BUT AIR WAS SEEN AS THE TUBING LEFT THE PUMP. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10839198 ↗
• MalfunctionNov 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE BAGS ARE LEAKING. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10810412 ↗