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Kangaroo 775100Recalls & reported problems

Cardinal Health, Inc. · Epump ENPlus Spike with Flush Bag,Anti-free Flow · Class 2

Quick summary

This Kangaroo ePump feeding set is tubing with a spike and flush bag for use with a Kangaroo tube feeding pump. The 988 reports often describe leaks, air being pulled into the tubing, and feed errors or clogs. There are no deaths or injuries. 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
988
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 988 adverse event reports that list this exact device (DI 10884521155817), received between Jun 6, 2017 and Sep 25, 2024 — classified as 988 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (900 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 2 reportsApr 2024: 0 reportsMay 2024: 2 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fluid/Blood Leak900
  • Leak/Splash55
  • Air/Gas in Device25
  • Detachment of Device or Device Component25
  • Break5
  • Detachment Of Device Component3
  • Occlusion Within Device2
  • Infusion or Flow Problem1

Patient problems

  • No Consequences Or Impact To Patient507
  • No Clinical Signs, Symptoms or Conditions219
  • No Known Impact Or Consequence To Patient169
  • No Patient Involvement64
  • Insufficient Information27
  • No Information10
  • Abdominal Distention1
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 25 most recent of 988 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 25, 2024Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THERE WAS AN ONGOING ISSUE WITH THE TUBE FEED TUBING PULLING AIR INTO THE LINE SHORTLY AFTER STARTING THE FEED. THE PATIENT IS ON BOLUS FEEDS AND STATED THIS ISSUE HAPPENED WITH EVERY FEED. THE TUBING WOULD INITIALLY PRIME, THEN WHEN THE FEED WAS STARTED IT WOULD IMMEDIATELY PULL AIR. WHEN TRYING TO REPRIME, THEY COULD SEE IT PULLING AIR INTO THE TUBING DESPITE THE FEED CONTAINER BEING NEW AND FULL. THREE PUMPS WERE USED, BUT THE ISSUE PERSISTED. THEY USED A DIFFERENT TUBING SET THAT CONTAINED 2 BAGS AND POURED THE FEED INTO THE BAG VERSUS SPIKING THE FEED CONTAINER. THIS SOLVED THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20303685 ↗
  • MalfunctionMay 22, 2024Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THE PATIENT WAS WITH INDICATION FOR BOLUSES OF GLUCERNA 283 ML EVERY 3 HOURS, IN THE ADMINISTRATION OF THE BOLUSES SINCE (B)(6) 2024. AIR WAS EVIDENCED IN THE EQUIPMENT THAT DESPITE PURGING THE KANGAROO PUMP WAS NOT POSSIBLE TO COMPLETE ADMINISTRATION OF NUTRITION SO THE EQUIPMENT WAS CHANGED ALLOWING THE CORRECT ADMINISTRATION. HOWEVER, THE NEXT DAY, DURING THE BOLUS ADMINISTRATION, AGAIN THE EQUIPMENT WAS WITH AIR AND THE PUMP GENERATED AN INFUSION ERROR ALARM. AFTER SEVERAL ATTEMPTS TO ADMINISTER ENTERAL NUTRITION DUE TO EQUIPMENT FAILURE, IT WAS NOT POSSIBLE; THEREFORE, THE EQUIPMENT HAD TO BE CHANGED AGAIN. IT WAS EVIDENCED THAT THE VALVE THAT IS FITTED IN THE PUMP DOES NOT FIT COMPLETELY. PROCESS STEP: DURING USE. THERE WERE NO OTHER DEFICIENT PRODUCTS USED DURING THE EVENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19371226 ↗
  • MalfunctionMay 7, 2024

    HEALTHCARE PROVIDER WENT THROUGH MULTIPLE KANGAROO PUMPS IN 4N14 THEN TRIED SWITCHING THE TUBING. ERROR MESSAGE KEPT STATING THERE WAS A FLOW ERROR. HEALTHCARE PROVIDER TRIED BOTH THE STANDARD SPIKE SET WITH A BAG AND THE DOUBLE BAG. THE DOUBLE BAG WORKED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19258345 ↗
  • MalfunctionMar 27, 2024Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT NURSES ARE SAYING THAT THERE IS AIR INSIDE THE TUBING OR BUBBLES AND IS CREATING A CLOG SOMETIMES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18989541 ↗
  • MalfunctionMar 27, 2024Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT NURSES ARE SAYING THAT THERE IS AIR INSIDE THE TUBING OR BUBBLES AND IT IS CREATING A CLOG SOMETIMES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18989049 ↗
  • MalfunctionJan 11, 2024Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED OVER THE WEEKEND THEY HAD MULTIPLE INSTANCES OF THE FEED TUBING FOR THE KANGAROO PUMPS (ONE BAG AND ONE SPIKE FOR THE FEED BOTTLE) THAT HAVE NOT PRIMED SUCCESSFULLY. ALL THE INSTANCES THEY HAVE HAD ISSUES WITH INVOLVE THE PRIMING PROCESS AND THE TUBING PULLING AIR INSTEAD OF FEED OR PULLING AIR IN ADDITION TO FEED MAKING THE TUBING FOAMY AND INSUFFICIENTLY PRIMED. TODAY THEY SUCCESSFULLY PRIMED THE PUMP WITH A THIRD SET OF TUBING FROM THE SAME LOT NUMBER THAT WORKED AS EXPECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18491958 ↗
  • MalfunctionAug 22, 2023Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THEY TESTED ONE EPUMP ENPLUS SPIKE WITH FLUSH BAG IN THE OFFICE AND GOT A FEED ERROR. THERE SEEMED TO BE AIR PULLING INTO THE LINE AT THE POINT WHERE THE FLUSH TUBING AND THE FEED TUBING CONNECT. THE STAFF NOTED INCREASED AIR IN THE TUBING AND IT IS NOT ALWAYS CAUSING THE PUMP TO ALARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17595126 ↗
  • MalfunctionJan 4, 2022Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THE SET WAS LEAKING AND THE TUBE HAD AIR BUBBLES. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13151210 ↗
  • MalfunctionOct 29, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THEY HAVE NOTICED AIR BUBBLES IN THE TUBING. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12723070 ↗
  • MalfunctionOct 29, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THEY HAVE NOTICED AIR BUBBLES IN THE TUBING. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12723048 ↗
  • MalfunctionOct 29, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THEY HAVE NOTICED AIR BUBBLES IN THE TUBING. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12722819 ↗
  • MalfunctionOct 29, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THEY HAVE NOTICED AIR BUBBLES IN THE TUBING. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12722647 ↗
  • MalfunctionOct 29, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THEY HAVE NOTICED AIR BUBBLES IN THE TUBING. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12722629 ↗
  • MalfunctionOct 29, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THEY HAVE NOTICED AIR BUBBLES IN THE TUBING. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12722614 ↗
  • MalfunctionOct 29, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THEY HAVE NOTICED AIR BUBBLES IN THE TUBING. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12722438 ↗
  • MalfunctionOct 29, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THEY HAVE NOTICED AIR BUBBLES IN THE TUBING. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12722364 ↗
  • MalfunctionOct 29, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THEY HAVE NOTICED AIR BUBBLES IN THE TUBING. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12722266 ↗
  • MalfunctionOct 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTS: THE DEVICE WAS INSTALLED AND A LEAK WAS OBSERVED FROM THE CONNECTION. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION WAS ASSOCIATED WITH THIS EVENT.

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

    MAUDE report 12606040 ↗
  • MalfunctionSep 28, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT AIR BUBBLES WERE NOTICED IN THE TUBING AND IN THE BOTTLE. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12544199 ↗
  • MalfunctionSep 28, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THE BOTTLE WAS FILLED WITH BUBBLES ABOVE THE TUBE FEEDING. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WERE BUBBLES IN THE TUBING LINE AND IN THE BOTTLE. THE BOTTLE USED WAS ABBOT NEPRO NUTRITION BOTTLE. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12543942 ↗
  • MalfunctionSep 28, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THERE SEEMS LIKE A LOT OF BUBBLES IN THE TUBE FEEDING BOTTLE, LIKE THERE IS A LEAK SOMEWHERE ALLOWING AIR TO GET IN. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WERE BUBBLES NOTED IN THE TUBING LINE, AND IN THE BOTTLE. THE BOTTLE USED WAS ABBOT NEPRO NUTRITION BOTTLE. THE CUSTOMER FURTHER STATED THAT THERE WAS NO LEAKING OBSERVED. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12543740 ↗
  • MalfunctionSep 28, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THEIR CLINICAL TEAM CONTINUING TO SEE BUBBLES IN THE TUBING. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12542515 ↗
  • MalfunctionSep 28, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THEY HAVE NOTICED AIR BUBBLES IN THE TUBING. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12542125 ↗
  • MalfunctionSep 28, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THEY HAVE NOTICED AIR BUBBLES IN THE TUBING. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12541858 ↗
  • MalfunctionSep 28, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THEY HAVE NOTICED AIR BUBBLES IN THE TUBING. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12541751 ↗

Other PUMP, INFUSION, ENTERAL devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.