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

Model Number 382400

Device Problems Excess Flow or Over-Infusion (1311); Patient Device Interaction Problem (4001)

Patient Problem Vomiting (2144)

Event Date 09/19/2021

Event Type  malfunction  

Event Description

My patient has been vomiting excessively throughout my shift, which is baseline for him, while he is waiting for his g-tube/nissen.I've (rn) had him two previous nights, but i noticed he is having more emesis tonight.His feed is running at 20ml/hr on a kangaroo pump.They increased his feeds from 19ml/hr to 20 ml/hr in the past 24 hours.I thought he was having more emesis because of the increase in volume.I have measured out my milk for the entire shift and calculated how much i needed to prep and warm every 4 hours.I noticed that my kangaroo pump bag was getting emptier faster than usual, but i thought i just did my math wrong.However, at 0630, i noticed that my kangaroo bag was empty again and i realized that i only have 60 ml of milk left in the fridge (formula that is made by dietary) and i knew it wasn't right.I traced my lines all night to make sure the connections were tight and secure.I think the kangaroo pump was overfeeding my patient and causing him to have increased emesis.I red-tagged the kangaroo pump and ran his feeds on a syringe pump.Technician's comments: found unit on during rounds with red tag indicating "loud beeping says "possibly over feeds".Checked unit's condition and performed unit verification.All tests passed.Returned to service.Please note: ifu, section ii, safety and warnings #14 "premature infants may require higher accuracy rates than specified for this enteral feeding pump".This event caused minimal temporary harm.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; building 5; mansfield MA 02048
• MDR Report Key: 12656125
• MDR Text Key: 277162560
• Report Number: 12656125
• 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: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2021
• Date Report to Manufacturer: 10/19/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 90 DA