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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH KANGAROO EPUMP ENPLUS SPIKE SET; PUMP, INFUSION, ENTERAL

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CARDINAL HEALTH KANGAROO EPUMP ENPLUS SPIKE SET; PUMP, INFUSION, ENTERAL Back to Search Results
Catalog Number 775659T
Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
On (b)(6) 2023: rn had tube feedings running and attempted to flush tubing and the feeding tube came apart in actual kangaroo pump area from the pressure.Rn attempted this three times with 4 different sets and all the same thing happened.Only 1 of the four sets saved.Sample returned to cardinal health for evaluation.On (b)(6) 2023: tube feeding tube cam apart where the tubing stretches in the pump.Was infusing in a ng tube.Lot: 22c013fhy the patient had the enfit salem sump, it had the y-extension on it with infusing and the nurse flushed it with 30cc water using the large enfit syringe within 30-60minutes of the tubing coming apart in the kangroo pump.Sample returned to cardinal health for evaluation.On(b)(6) 2023: [nurse] was giving patient medications with enfit ng which worked fine.Tube feeding running and [nurse] paused to give meds through the "y" connector.No issues with giving medications and seem to flow easily.While instilling meds, kangaroo pump began leaking tube feeding.Came apart at connection that we have been having issues with coming apart.All supplies used where enfit products.Lot unknown awaiting shipping label to return to cardinal health for evaluation.Reference report: mw5115310, mw5115312, mw5115313.
 
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Brand Name
KANGAROO EPUMP ENPLUS SPIKE SET
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
CARDINAL HEALTH
MDR Report Key16459742
MDR Text Key310545890
Report NumberMW5115311
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/24/2023
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 Health Professional
Device Catalogue Number775659T
Device Lot Number22C013FHY
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/28/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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