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Kangaroo 674655Recalls & reported problems

Cardinal Health, Inc. · Kangaroo Epump Proximal Spike Set, Anti-free Flow · Class 2

Adverse event reports
9
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521028203), received between Nov 19, 2020 and Feb 8, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (7 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

  • Air/Gas in Device7
  • Infusion or Flow Problem2

Patient problems

  • Abdominal Distention5
  • Discomfort5
  • Nausea5
  • Vomiting5
  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 8, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THEY IDENTIFIED A LARGE AMOUNT OF AIR IN THE EQUIPMENT, EVEN WHEN FOLLOWING THE EQUIPMENT PLACEMENT GUIDELINES WITH THE PUMP TURNED OFF. THE ISSUE HAPPENED WITH 10 FEEDING SETS FROM THE SAME LOT AND WERE DISCARDED. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11294712 ↗
  • MalfunctionJan 26, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THE DEVICE WAS SIGNALING AIR INTAKE AT THE CROSS SENSOR. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11230068 ↗
  • MalfunctionJan 5, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THE LANCET TIP ENTERAL FEEDING TEAM HAD A PROBLEM WHERE THERE WAS AIR INTAKE IN THE LINE OF THE FEEDING SET DURING ADMINISTRATION OF THE ENTERAL DIET. IT WAS NECESSARY TO CHANGE THE EQUIPMENT TO CONTINUE THE ADMINISTRATION OF THE DIET AS THE AIR IN THE LINE CAUSED THE PATIENT DISCOMFORT, CONSIDERABLE ABDOMINAL DISTENTION, NAUSEA, AND VOMITING. WHEN THE FEEDING SET WAS REPLACED WITH A SET FROM ANOTHER BATCH THE PROBLEM WAS RESOLVED.

    Patient problems: Abdominal Distention; Discomfort; Nausea; Vomiting

    MAUDE report 11121070 ↗
  • MalfunctionJan 5, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THE LANCET TIP ENTERAL FEEDING TEAM HAD A PROBLEM WHERE THERE WAS AIR INTAKE IN THE LINE OF THE FEEDING SET DURING ADMINISTRATION OF THE ENTERAL DIET. IT WAS NECESSARY TO CHANGE THE EQUIPMENT TO CONTINUE THE ADMINISTRATION OF THE DIET AS THE AIR IN THE LINE CAUSED THE PATIENT DISCOMFORT, CONSIDERABLE ABDOMINAL DISTENTION, NAUSEA, AND VOMITING. WHEN THE FEEDING SET WAS REPLACED WITH A SET FROM ANOTHER BATCH THE PROBLEM WAS RESOLVED.

    Patient problems: Abdominal Distention; Discomfort; Nausea; Vomiting

    MAUDE report 11120967 ↗
  • MalfunctionDec 16, 2020Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THE LANCET TIP ENTERAL FEEDING TEAM HAD A PROBLEM WHERE THERE WAS AIR INTAKE IN THE LINE OF THE FEEDING SET DURING ADMINISTRATION OF THE ENTERAL DIET. IT WAS NECESSARY TO CHANGE THE EQUIPMENT TO CONTINUE THE ADMINISTRATION OF THE DIET AS THE AIR IN THE LINE CAUSED THE PATIENT DISCOMFORT, CONSIDERABLE ABDOMINAL DISTENTION, NAUSEA, AND VOMITING. WHEN THE FEEDING SET WAS REPLACED WITH A SET FROM ANOTHER BATCH THE PROBLEM WAS RESOLVED.

    Patient problems: Abdominal Distention; Discomfort; Nausea; Vomiting

    MAUDE report 11018521 ↗
  • MalfunctionDec 16, 2020Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THE LANCET TIP ENTERAL FEEDING TEAM HAD A PROBLEM WHERE THERE WAS AIR INTAKE IN THE LINE OF THE FEEDING SET DURING ADMINISTRATION OF THE ENTERAL DIET. IT WAS NECESSARY TO CHANGE THE EQUIPMENT TO CONTINUE THE ADMINISTRATION OF THE DIET AS THE AIR IN THE LINE CAUSED THE PATIENT DISCOMFORT, CONSIDERABLE ABDOMINAL DISTENTION, NAUSEA, AND VOMITING. WHEN THE FEEDING SET WAS REPLACED WITH A SET FROM ANOTHER BATCH THE PROBLEM WAS RESOLVED.

    Patient problems: Abdominal Distention; Discomfort; Nausea; Vomiting

    MAUDE report 11018508 ↗
  • MalfunctionDec 15, 2020Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT THE LANCET TIP ENTERAL FEEDING TEAM HAD A PROBLEM WHERE THERE WAS AIR INTAKE IN THE LINE OF THE FEEDING SET DURING ADMINISTRATION OF THE ENTERAL DIET. IT WAS NECESSARY TO CHANGE THE EQUIPMENT TO CONTINUE THE ADMINISTRATION OF THE DIET AS THE AIR IN THE LINE CAUSED THE PATIENT DISCOMFORT, CONSIDERABLE ABDOMINAL DISTENTION, NAUSEA, AND VOMITING. WHEN THE FEEDING SET WAS REPLACED WITH A SET FROM ANOTHER BATCH THE PROBLEM WAS RESOLVED.

    Patient problems: Abdominal Distention; Discomfort; Nausea; Vomiting

    MAUDE report 11012971 ↗
  • MalfunctionNov 19, 2020Infusion or Flow Problem; Infusion or Flow Problem

    THE CUSTOMER REPORTED THAT BUBBLES APPEARED DURING INFUSION. NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10872074 ↗
  • MalfunctionNov 19, 2020Infusion or Flow Problem; Infusion or Flow Problem

    THE CUSTOMER REPORTED THAT BUBBLES APPEARED DURING INFUSION. NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10872049 ↗

Other Pump, Infusion, Enteral devices

All Pump, Infusion, Enteral devices →

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