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

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, mw5115311, mw5115312.

• Brand Name: KANGAROO EPUMP ENPLUS SPIKE SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 16459807
• MDR Text Key: 310547360
• Report Number: MW5115313
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 775659T
• Device Lot Number: 22C013FHY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1