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Kangaroo 775659Recalls & reported problems

Cardinal Health, Inc. · Epump Safety Screw Spike Set,Anti-free Flow · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This Cardinal Health Kangaroo tube feeding set has 139 adverse event reports, including 1 death and 1 injury. Many describe feeding tubing leaking, bursting or spilling, and air bubbles blocking the 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
139
Deaths reported
1
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 10884521155831), received between Aug 8, 2017 and Dec 28, 2022 — classified as 1 death, 1 injury, 137 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (84 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 Leak84
  • Leak/Splash37
  • Air/Gas in Device11
  • Detachment of Device or Device Component9
  • Infusion or Flow Problem3
  • Adverse Event Without Identified Device or Use Problem2
  • Break2
  • Detachment Of Device Component2

Patient problems

  • No Clinical Signs, Symptoms or Conditions48
  • No Consequences Or Impact To Patient48
  • No Known Impact Or Consequence To Patient29
  • No Patient Involvement8
  • Insufficient Information5
  • No Information2
  • Aspiration/Inhalation1
  • Death1

Recent adverse event reports

The 25 most recent of 139 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 28, 2022Break; Burst Container or Vessel; Complete Blockage; Fluid/Blood Leak; Detachment of Device or Device Component

    WE HAVE HAD AT LEAST 6 INCIDENTS SINCE AUGUST, MOST OCCURRING IN NOVEMBER, OF KANGAROO TUBING BURSTING AND SPILLING: PATIENT WAS CONNECTED TO TUBE FEEDING PUMP AT A RATE OF 90ML/HR. TUBE FEEDING TUBING BURST OPEN AND LEAKED TUBE FEEDING EVERYWHERE. TUBING BURST OPEN AT A CONNECTION ON THE TUBE FEEDING TUBING. TUBING HAS BEEN SAVED. TUBE FEEDING PUMP MALFUNCTIONED FOR A PATIENT THAT IS ON AN INSULIN DRIP. THE TUBING INSIDE WAS SEPARATED AT THE TURN WHEEL SO THE TUBE FEEDING ENDED UP LEAKING OUT THROUGH THAT OPENING BUT THE MACHINE KEPT RUNNING. RN NOTICED A LARGE POOLING OF TUBE FEEDINGS ON THE FLOOR AND SWITCHED THE TUBING. THE NASODUODENAL TUBE ENDED UP GETTING CLOGGED BECAUSE THE TUBE HAD DORMANT TUBE FEEDING SITTING IN IT FOR UNKNOWN AMOUNT OF TIME. NASODUODENAL TUBE WAS ABLE TO BE UNCLOGGED WITH WARM WATER. THE TUBING WAS CHANGED AND THIS PROBLEM OCCURRED A SECOND TIME WHERE THE TUBING BROKE IN HALF AT THE WHEEL. NEW PUMP WAS ORDERED AND BLOOD SUGAR REMAINED STABLE. KANGAROO EPUMP TUBING BROKE OFF AT CONNECTION SITE. TUBE FEEDS LEAKED ALL OVER. KANGAROO EPUMP TUBING BROKE OFF AT CONNECTION SITE. TUBE FEEDS LEAKED ALL OVER. TUBING SAVED AND GIVEN TO CNS. THIS IS THE SECOND TIME

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16060669 ↗
  • MalfunctionDec 20, 2022Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THE EQUIPMENT PRESENTS AIR. THE DIET DOES NOT FILL THE EQUIPMENT AND DOES NOT PRIME UNTIL THE GASTROSTOMY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16015952 ↗
  • MalfunctionAug 2, 2022Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THE TUBING IS DEFECTIVE AND IT MAKES BUBBLES DURING A FEED. IT ALSO APPEARS THAT THE TUBING IS PINCHED AND CAUSES FEED ERRORS. PER ADDITIONAL INFORMATION RECEIVED ON 25-JUL-2022, NOTHING WAS REPLACED. THEY WE¿RE JUST HAVING PROBLEMS WITH THE WIRING TUBE AS IT GETS BUBBLES INSIDE AND BLOCKS THE MACHINE. WHEN THEY CHANGE IT, SOMETIMES IT WORKS, AND SOMETIMES THEY NEED TO CHANGE IT FIVE TIMES. THERE¿S A DEFECT WITH THE WIRING TUBE ITSELF. THEY HAVE HAD THE MACHINE AND FORMULA CHECKED AND THEY ARE FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15153321 ↗
  • MalfunctionJul 27, 2022Air/Gas in Device

    THE CUSTOMER REPORTED THAT THERE ARE AIR BUBBLES IN THE TUBE WHICH IS BLOCKING THE TUBE FROM FUNCTIONING AND MAKING THE MACHINE RING. NO INJURIES OCCURRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15113540 ↗
  • MalfunctionSep 9, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

    THE CUSTOMER REPORTED THE ENTERAL TUBE BROKE. ADDITIONAL INFORMATION RECEIVED STATED THE BREAK WAS IN THE SILICONE PART CAUSING A LEAK IN THE DIET. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12447727 ↗
  • MalfunctionAug 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED A PROBLEM IN THE CONNECTION OF THE ENTERAL TUBE WITH THE DIET BOTTLE, CAUSING LEAKAGE. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12360246 ↗
  • MalfunctionAug 24, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THE DIET DOES NOT FLOW IN THE ENTERAL TUBE; THERE SEEMS TO BE AIR IN THE TUBE. THE CUSTOMER STATED THAT EVEN AFTER PRIMING, THE DIET DOES NOT FLOW. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12360063 ↗
  • MalfunctionAug 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

    CUSTOMER REPORTS: THE DEVICE LEAKED IN THE ENTERAL TUBE NEAR THE PORTION THAT CONNECTS TO THE ENTERAL DIET BOTTLE.

    Patient problems: Insufficient Information

    MAUDE report 12359516 ↗
  • MalfunctionJun 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE ENTERAL TUBE PRESENTED A LEAK IN THE CONNECTION, FOLLOWED BY RUPTURE OF THE TUBE. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12032835 ↗
  • MalfunctionJun 21, 2021Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

    THE CUSTOMER REPORTED DURING PATIENT HYDRATION THROUGH THE NASOENTERAL TUBE, THE ENTERAL TUBE RUPTURED IN THE SILICONE REGION OF THE FEEDING SET. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12032243 ↗
  • MalfunctionJun 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THE ENTERAL TUBE IS LEAKING BELOW THE SPIKE TIP THAT CONNECTS WITH THE ENTERAL BAG DIET. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12032137 ↗
  • MalfunctionJun 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE TUBING OF THE ENTERAL FEEDING SET DISCONNECTED FROM THE SILICONE PART WHEN TURNING ON THE INFUSION PUMP. THE SET DID NOT INFUSE THE DIET AND LEAKED INTO THE INFUSION PUMP. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12025389 ↗
  • MalfunctionJun 17, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

    CUSTOMER REPORTS: THE SILICONE PORTION OF THE ENTERAL TUBE DISCONNECTED AND THE DIET NUTRITION LEAKED.

    Patient problems: Insufficient Information

    MAUDE report 12016343 ↗
  • MalfunctionJun 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

    AS REPORTED THROUGH ANVISA NOTIFICATION (B)(4) - THE NUTRITION DIET WAS LEAKING FROM THE EQUIPMENT.

    Patient problems: Insufficient Information

    MAUDE report 11979621 ↗
  • MalfunctionMay 17, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE ENTERAL FEEDING SET HAD A LEAK IN THE DIET BETWEEN THE EQUIPMENT AND THE DIET BAG. NO PATIENT INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11838206 ↗
  • MalfunctionMay 14, 2021Fluid/Blood Leak; Obstruction of Flow; Fluid/Blood Leak; Obstruction of Flow

    THE CUSTOMER REPORTED THROUGH ANVISA NOTIFICATION THE FEEDING SET BROKE IN THE PUMP CIRCUIT DUE TO RESISTANCE/OBSTRUCTION OF THE ENTERAL TUBE. THE PUMP DIDN'T ALARM WHEN THE TUBE BROKE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11826596 ↗
  • MalfunctionMay 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED A DISCONNECTION OF THE EQUIPMENT PORTION CAUSING THE DIET TO LEAK. NO OTHER INFORMATION IS ABLE TO BE OBTAINED SINCE THE REPORTER'S INFORMATION WAS NOT PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11823085 ↗
  • MalfunctionMay 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

    AS REPORTED THROUGH ANVISA: THE EQUIPMENT DISCONNECTED AT THE SILICONE PART WHEN TURNING ON THE INFUSION. THE PUMP, DOES NOT INFUSE THE DIET AND LEAKS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11814194 ↗
  • MalfunctionMay 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

    AS REPORTED THROUGH ANVISA: THE DEVICE LEAKED AT THE CONNECTION, FOLLOWED BY A RUPTURE OF THE CONNECTOR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11814077 ↗
  • MalfunctionMay 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

    AS REPORTED THROUGH THE ANVISA NOTIFICATION: DURING AN ONGOING DIET NUTRITION FEED THERE WAS A RUPTURE OF THE SILICONE PART OF THE EQUIPMENT.

    Patient problems: Insufficient Information

    MAUDE report 11813878 ↗
  • MalfunctionMay 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT DURING THE HYDRATION OF THE PATIENT BY THE SNE, THE FEEDING SET PRESENTED A RUPTURE IN THE SILICONE REGION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11813003 ↗
  • MalfunctionMay 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE FEEDING SET SHOWED A LEAK BELOW THE TIP THAT CONNECTS WITH THE ENTERAL DIET. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11812849 ↗
  • MalfunctionMay 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

    AS REPORTED THROUGH THE ANVISA NOTIFICATION: THE EQUIPMENT APPEARED RUPTURED IN THE SILICONE REGION RESULTING IN A LEAKAGE OF THE ENTERAL DIET.

    Patient problems: Insufficient Information

    MAUDE report 11812789 ↗
  • MalfunctionApr 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE EQUIPMENT BURST INSIDE THE BI. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11739767 ↗
  • MalfunctionApr 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE EQUIPMENT DISCONNECTED FROM THE ROLLER AND THE DIET LEAKED. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11738202 ↗

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Sources and updates

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