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

Device Problems Excess Flow or Over-Infusion (1311); Product Quality Problem (1506); Application Program Problem: Medication Error (3198)

Patient Problems Overdose (1988); Abdominal Distention (2601)

Event Date 10/02/2019

Event Type  malfunction  

Event Description

I was doing the initial feeding with this kangaroo pump- this was going to be the first time the pump was used with the patient, and i noted the screen looked different than usual.There was an interval bolus and some other words regarding a bolus on the pump's screen that i have never seen before.I thought maybe there had been an update to the kangaroo pump's systems and continued to program the pump as i am accustomed to.The patient was to get one bolus of 320ml at 320ml/hr.I was held up in another patient's room and when i went to round on the patient was surprised i didn't hear the beep of the kangaroo pump feeding being complete.Upon examining the tube feed container, i noted that more than 320ml was gone.I tried to clear the volume on the pump to see how much the patient had received and there was not an option to view the amount of intake or to see how much the patient took in.There was an entry for boluses administered which said "1" but the patient had definitely received more than 1 bolus, more likely two boluses of tf.The kangaroo pump had continued to give the tf bolus every hour, so the patient received two 320 boluses, instead of stopping after one feed.The nurse practitioner was notified right away and 350ml was removed from patient's gastric tube.Patient reported feeling distended but better after the 350ml was removed.Patients lungs were also auscultated for any crackles or adventitious sounds, none were noted.Patient did not vomit either.Another nurse was brought in to examine pump and nurse stated she had never seen a kangaroo pump have that set up before.The nurse educator was also brought in who had never seen the kangaroo pump set up like this one.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 300 south riverside plaza; chicago IL 60606
• MDR Report Key: 9284362
• MDR Text Key: 165235345
• Report Number: 9284362
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/03/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27375 DA