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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KANGAROO ENTERAL FEEDING PUMP SETS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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CARDINAL HEALTH 200, LLC KANGAROO ENTERAL FEEDING PUMP SETS; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Lot Number 202580052
Device Problem Gas/Air Leak (2946)
Patient Problems Abdominal Pain (1685); Dehydration (1807); Hypoglycemia (1912); Vomiting (2144); Abdominal Distention (2601)
Event Type  Injury  
Event Description
Letter was received stating pump sets may cause excessive air entry into the feed lines and can lead to certain health consequences.Including vomiting, dehydration, hypoglycemia, abdominal pain and abdominal distention in patients.In this case the patient, (b)(6), a minor child has experienced vomiting, dehydration, hypoglycemia, abdominal pain and abdominal distention and has been to her gi doctor for all the above over the last several months, tests have been done to include blood work, and even reducing her feed rate and even discontinued her feed due to the above issues.Four nurses can attest to the facts above, as well as clinical notes from the gi doctor, as well as other healthcare professionals.We are in possession of over 50 bags which fall under the companies letter of correction.See scanned pages.
 
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Brand Name
KANGAROO ENTERAL FEEDING PUMP SETS
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
MDR Report Key11607832
MDR Text Key243768491
Report NumberMW5100507
Device Sequence Number1
Product Code KNT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nursing Assistant
Type of Report Initial
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number202580052
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other; Required Intervention;
Patient Age9 YR
Patient Weight29
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