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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO EPUMP ENPLUS SPIKE WITH FLUSH BAG,ANTI-FREE FLOW; PUMP, INFUSION, ENTERAL
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CARDINAL HEALTH, INC. KANGAROO EPUMP ENPLUS SPIKE WITH FLUSH BAG,ANTI-FREE FLOW; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 775100
Device Problem Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 08/23/2021
Event Type  malfunction  
Event Description
Tube feeding sets leaking.Nurse hung a new tube feeding bag with a new set and it was leaking from the tubing and not from the bag.The nurse switched out tubing to a new set (same lot number as leaking tubing) and the leaking stopped.The nurse saved the tube feeding set that had the leak.While not officially reported through our safety first reporting system, the nurse also indicated that this same event with leaking tubing occurred the previous day.Nurse reported had a total of three different sets of the kangaroo pump tubing that leaked at the insertion point.
 
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Brand Name
KANGAROO EPUMP ENPLUS SPIKE WITH FLUSH BAG,ANTI-FREE FLOW
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
CARDINAL HEALTH, INC.
15 hampshire street
building 5
mansfield MA 02048
MDR Report Key12413225
MDR Text Key269516539
Report Number12413225
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number775100
Device Catalogue Number775100
Device Lot Number211440061
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/30/2021
Event Location Hospital
Date Report to Manufacturer09/02/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age16425 DA
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