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Kangaroo 672055Recalls & reported problems

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

Adverse event reports
11
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521028142), received between Oct 22, 2019 and Aug 12, 2021 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 Leak9
  • Air/Gas in Device2

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • No Consequences Or Impact To Patient4
  • No Patient Involvement2

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE PHARMACIST REPORTED THE PRODUCT WAS DISPENSED FROM AN AUTOMATED CABINET AND ENTERAL NUTRITION ADMINISTRATION WAS STARTED. AFTER A SHORT PERIOD OF TIME (NOT SPECIFIED) THERE WAS EVIDENCE OF DRIPPING FROM THE BAG ON ONE SIDE, AT THE CONNECTION POINT BETWEEN THE BAG AND THE INFUSION PUMP. WHEN CHECKING, A RUPTURE WAS FOUND, SO A NEW BAG WAS REQUESTED. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12312859 ↗
  • MalfunctionAug 6, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT AFTER ONE HOUR OF ADMINISTRATION, THE PUMP SOUNDS (ALARMS) AND DOES NOT ALLOW PRIMING OF THE EQUIPMENT. THE ISSUE OCCURRED DURING USE WITH A PATIENT WHO IS ADMINISTERED ENTERAL NUTRITION BY GASTRONOMY TUBE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED ON 27-JUL-2021 STATES THAT WHEN THE PUMP ALARMED THEY LOOKED TO VERIFY THE REASON WHY AND FOUND THAT THE DEVICE HAD AIR. THEY THEN TRIED TO PRIME IT BUT WAS UNABLE TO.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12291860 ↗
  • MalfunctionJun 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT NUTRITION LEAKED AT THE LOCATION OF THE PURPLE CONNECTOR. THE ISSUE OCCURRED DURING PRIMING. PATIENT WAS NOT INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11988023 ↗
  • MalfunctionFeb 16, 2021Air/Gas in Device; Air/Gas in Device

    THE CUSTOMER REPORTED THAT WHEN PRIMING THE SET HAD AIR INSIDE AND IT WAS UNABLE TO PRIME. THE MACHINE WAS CHANGED BUT THE PROBLEM PERSISTED. THE SET WAS CHANGED AND THEY WERE ABLE TO CONTINUE WITH THE THERAPY. THE OPERATOR OF THE PRODUCT INVOLVED WAS A HEALTHCARE PROFESSIONAL. CUSTOMER HAS CONFIRMED THAT ACTUAL SAMPLE IS NOT AVAILABLE FOR EVALUATION, SAMPLE WAS DISCARDED BY THE CUSTOMER. THERE ARE NO COMPANION SAMPLES TO BE RETURNED. THERE ARE NO OTHER DEFICIENT PRODUCTS USED DURING THE EVENT. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11335671 ↗
  • MalfunctionDec 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT AT THE TIME OF STARTING THE ENTERAL NUTRITION DURING PRIMING, THE NUTRITION WAS CONNECTED TO THE SET AND IT WAS NOTICED THAT THERE WAS A LEAK FROM THE PERIPHERY. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11087278 ↗
  • MalfunctionDec 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT DURING PRIMING, A NUTRITION LEAK WAS EVIDENCED ON ONE SIDE, AS THE THREAD DID NOT WORK. THERE WAS NO PATIENT INVOLVED; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT.

    Patient problems: No Patient Involvement

    MAUDE report 10938513 ↗
  • MalfunctionApr 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT 1 UNIT WAS BROKEN AT THE BEGINNING OF THE LINE. THE EVENT OCCURRED DURING PRIMING. THERE WAS PATIENT INVOLVEMENT; BUT, NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE REACTION. THE SAMPLE RECEIVED FOR INVESTIGATION WAS FOUND TO HAVE A LEAK BETWEEN THE BAG AND THE LINE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10007320 ↗
  • MalfunctionApr 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THERE WAS EVIDENCE OF A NUTRITION LEAK IN THE SET VALVE. THERE WAS PATIENT INVOLVEMENT BUT NOT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTIONS WERE ASSOCIATED WITH THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9912413 ↗
  • MalfunctionMar 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT DURING USE, IT WAS EVIDENT THAT THE PUMP SHOWED WATER AND NUTRITION IN THE CASSETTE. THERE WAS NO HARM TO THE PATIENT INVOLVED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9793335 ↗
  • MalfunctionDec 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THE FEEDING SET PRESENTED WATER FILTRATION IN THE UNION OF THE BAG WITH THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT THEREFOR THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION ASSOCIATED WITH THIS EVENT.

    Patient problems: No Patient Involvement

    MAUDE report 9402700 ↗
  • MalfunctionOct 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE BAG LEAKED DURING PRIMING.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9218760 ↗

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.