Kangaroo 773662 (UDI 30884521022106)Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 30884521022106), received between Apr 10, 2019 and Nov 15, 2022 — classified as 79 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (67 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 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2022Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THAT DURING NUTRITION ADMINISTRATION AIR BUBBLES WERE OBSERVED INSIDE THE SET DESPITE IT WAS PRIMED SEVERAL TIMES. THE PUMP WAS CHANGED THE PROBLEM PERSISTED AND WHEN THE SET WAS CHANGED, THE PROBLEM WAS RESOLVED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION WAS ASSOCIATED WITH THIS EVENT; VIDEO PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15797597 ↗
• MalfunctionNov 15, 2022Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THAT DURING NUTRITION ADMINISTRATION, AIR WAS EVIDENCED IN THE DEVICE. THE DEVICE WAS PRIMED SEVERAL TIMES BUT THE FAILURE CONTINUED. FINALLY, THE BAG WAS SWAPPED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796904 ↗
• MalfunctionAug 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT A (B)(6) -YEAR-OLD FEMALE PATIENT WITH A POSITIVE COVID-19 DIAGNOSIS REQUIRED THE INSTALLATION OF ENTERAL NUTRITION EQUIPMENT AND WHEN WATER WAS ADDED TO ONE OF THE BAGS, THE LIQUID CAME OUT OF ONE OF THE EDGES OF THE BAG. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356962 ↗
• MalfunctionAug 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE ENTERAL FEEDING SET HAD A CUT ON THE BAG WHICH CAUSED AN EXTERNAL NUTRITION LEAKAGE. PATIENT WAS INVOLVED, BUT NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356892 ↗
• MalfunctionAug 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: DURING USE IT WAS EVIDENT THAT THE BAG WAS BROKEN IN THE LOWER CORNER WHICH CAUSED THE ENTERAL NUTRITION TO BE COMPLETELY LOST. A PATIENT WAS INVOLVED, BUT NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION WAS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338789 ↗
• MalfunctionAug 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING PRIMING THEY NOTICED AN EXTERNAL LEAK AT THE PORT. PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305210 ↗
• MalfunctionAug 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT A (B)(6) YEAR-OLD MALE PATIENT WITH CARDIAC ARREST, WHO REQUIRED THE INSTALLATION OF ENTERAL NUTRITION HAD FLUID LEAKAGE IN THE LOWER PART OF THE BAG WHERE THE HOLE IS LOCATE. THE ISSUE OCCURRED PRIOR TO USE, A PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305189 ↗
• MalfunctionAug 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING SETUP/PREPARATION THERE WAS A SOLUTION LEAKAGE IN THE HOLE NEAR THE CONNECTOR. THERE WAS PATIENT INVOLVEMENT; BUT, NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE REACTION WAS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305185 ↗
• MalfunctionJul 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING PRIMING THE SET PRESENTED LEAK AT THE FLUSH BAG. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229308 ↗
• MalfunctionJul 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHILE PRIMING THEY NOTICED A LEAK FROM THE SEAL OF THE TUBING AND BAG. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12219181 ↗
• MalfunctionJul 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHILE PRIMING THEY NOTICED A LEAK FROM THE SEAL OF THE TUBING AND BAG. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12219106 ↗
• MalfunctionJul 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE FEEDING SET PRESENTED A LEAK THROUGH THE IRRIGATION WATER BAG DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188743 ↗
• MalfunctionJul 12, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE TUBE FROM THE FEED BAG SEPARATED FROM THE VALVE, WHERE THE FEED AND FLUSH LINES JOIN THE VALVE AT THE PUMP, CAUSING A LEAK. THE CUSTOMER NOTICED THIS WHILE FILLING THE BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12152377 ↗
• MalfunctionJul 12, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  THE CUSTOMER REPORTED THE FLUSH BAG HAD A PINHOLE LEAK IN THE TUBING BETWEEN THE BAG AND THE VALVE. THE CUSTOMER NOTICED THIS WHILE FILLING THE BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12151294 ↗
• MalfunctionJul 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE FLUSH BAG LEAKED AT THE NECK, WHERE THE CAP IS ATTACHED TO THE TOP OF THE BAG. THE CUSTOMER NOTICED THIS WHILE FILLING THE BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12151141 ↗
• MalfunctionJun 22, 2021Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED ISSUES WITH AIR GETTING INTO THE FEEDING TUBE BAG LINES. SHE STATED HER SON HAS EXPERIENCED INTENSE CRAMPING EARLY IN THE MORNING AFTER FEEDING ALL NIGHT. SHE HAS ALSO NOTICED EXTRA FORMULA THAT SHOULD NOT STILL BE IN THE BAG AFTER RUNNING ALL NIGHT SO HE IS NOT GETTING ALL OF THE FORMULA THAT IS SUPPOSED TO BE DISTRIBUTED VIA THE ML/RATE PER HOUR. ADDITIONAL INFORMATION PROVIDED ON 21-JUN-2021 STATED THAT THE PRODUCT WAS EPUMP SET WITH FLUSH BAG (ANTI-FREE FLOW 1000ML). THE PATIENT IS A (B)(6) MALE WITH GASTROPARESIS. THEY DID NOT SEEK MEDICAL ATTENTION IMMEDIATELY, BUT THIS ISSUE HAD BEEN GOING ON INTERMITTENTLY OVER SEVERAL WEEKS AND DID RESULT IN CONSULTING THE PATIENT'S GI DOCTOR, NUTRITIONIST AND DIETITIAN TO TRY AND FIGURE OUT WHY THIS WAS A NEW SYMPTOM. THE PATIENT HAD BEGGED HIS PARENT SEVERAL TIMES TO NOT HOOK HIM UP BECAUSE THE PAIN HE FELT WAS ASSOCIATED WITH THE FEEDINGS. THE PATIENT LOST 10+ POUNDS AND THEY WERE CONTEMPLATING CHANGING FORMULAS, BUT HE HAD BEEN DOING FINE ON THIS SPECIAL FORMULA LEAVING THEM PERPLEXED. ON (B)(6) 2021 THE INITIAL REPORTER CONFIRMED THERE WAS NO TREATMENT OR MEDICATION GIVEN TO THE PATIENT. THEY DROVE 10 HOURS ROUND

  Patient problems: Abdominal Cramps; Weight Changes

  MAUDE report 12046481 ↗
• MalfunctionJun 14, 2021Air/Gas in Device; Air/Gas in Device

  CUSTOMER REPORTS: AIR HAD ENTERED INTO THE TUBING.

  Patient problems: Insufficient Information

  MAUDE report 11991447 ↗
• MalfunctionJun 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THERE WAS A NUTRITION LEAK THROUGH A SIDE HOLE DURING USE WITH A PATIENT WITH ENTERAL NUTRITION ORDER. THERE WAS PATIENT INVOLVEMENT; BUT NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE REACTION WAS REPORTED ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987987 ↗
• MalfunctionMay 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TUBING FROM THE BAG OF THE FEEDING SET WAS LEAKING WATER INTO THE VALVE-POCKET OF THE PUMP. ALSO, WATER WAS LEAKING OUT OF THE TUBING FROM THE BAG THAT GOES AROUND THE ROTOR. ALL OF THIS RESULTED IN A FLOW ERROR SIGNAL. IT APPEARED THAT THE LEAKING OCCURS AFTER THEY USE THE FLUSH FEATURE OF THE PUMP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11859908 ↗
• MalfunctionMay 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TUBING FROM THE BAG OF THE FEEDING SET WAS LEAKING WATER INTO THE VALVE-POCKET OF THE PUMP. ALSO, WATER WAS LEAKING OUT OF THE TUBING FROM THE BAG THAT GOES AROUND THE ROTOR. ALL OF THIS RESULTED IN A FLOW ERROR SIGNAL. IT APPEARED THAT THE LEAKING OCCURS AFTER THEY USE THE FLUSH FEATURE OF THE PUMP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842167 ↗
• MalfunctionApr 13, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  THE CONSUMER CALLED IN TO REPORT THAT THE FEEDING SETS DO NOT STAY CONNECTED WITH HIS FEEDING TUBE. THE FEEDING SET DISCONNECTS CAUSING LEAKING. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11656672 ↗
• MalfunctionApr 13, 2021Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER STATES THAT THERE ARE AIR GAPS OF 3 TO 4 INCHES. THE USER HAS EXPERIENCED BLOATING AND OCCASIONAL DIARRHEA.

  Patient problems: Abdominal Distention

  MAUDE report 11656430 ↗
• MalfunctionMar 30, 2021Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THAT THEY HAVE BEEN DEALING WITH EXCESS AIR IN THE TUBING ON A REGULAR BASIS WHICH HAS EXACERBATED THEIR GI ISSUES. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT THE ISSUE HAS BEEN INTERMITTENT AND ONGOING. THE CUSTOMER HAS HAD SYMPTOMS OF NAUSEA, WINDY AND BLOATING. THE CUSTOMER DID NOT REQUIRE ANY TREATMENT OR INTERVENTION FOR THE REPORTED INCIDENT AND DID NOT SEE A HEALTH CARE PROFESSIONAL FOR THESE ISSUES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Flatus; Nausea

  MAUDE report 11592931 ↗
• MalfunctionFeb 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE FEEDING SET PRESENTED THE SPLICING OF LINES WITH A LEAK. THE OPERATOR OF THE PRODUCT INVOLVED IS UNKNOWN. 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 11358531 ↗
• MalfunctionJan 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE NURSE INSTALLED THE ENTERAL NUTRITION SET AND DURING THE ADMINISTRATION OF NUTRITION, A LEAK WAS DETECTED. A TINY HOLE WAS OBSERVED AT THE LEVEL OF THE VALVE WHERE THE SET IS INSTALLED TO THE PUMP. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11205136 ↗