MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO; PUMP, INFUSION, ENTERAL

Model Number 382400

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Weight Changes (2607)

Event Date 11/21/2020

Event Type  No Answer Provided  

Event Description

Kangaroo pump feedings not administering accurate amounts of enteral feeds.Ex 31+4 wker, now 40 wks receiving enteral feeds via kangaroo pump @ 19ml/hr.Pt has not had good weight gain trend over last few weeks.Rn noticed that a large amount of enteral feed was left in the bag at the time when feeding bag was due to be rinsed.Rn switched to syringe pump for feeding sand ran kangaroo pump into a bucket.When the kangaroo pump stated it had given 49 mls of feedings, only 40ml was in the bucket.According to the instructions for the kangaroo pump found online, "this enteral feeding pump should only be used for patients who can tolerate the flow rates and accuracy levels delivered by the pump.Premature infants may require higher accuracy rates than specified for this enteral pump.The manual also states that the feeds can be +/- 4% of the desire volume.Do not use kangaroo pump for the nicu population.Use syringe pumps or find a different, more accurate pump.20% discrepancy between what pump said it dispensed and what was measured as output for this patient.Technician's comments: rounded for unit in room.Removed it and brought it for testing.Checked unit's condition and ran unit verification 3 times.All tests passed.This is all the information we have available.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 444 mcdonnell blvd.; hazelwood MO 63042
• MDR Report Key: 11257820
• MDR Text Key: 229590878
• Report Number: 11257820
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 382400
• Device Catalogue Number: C17165265
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 280 DA