MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY ENTERAL PUMP

Catalog Number AMERICAN HOME PATIENT# 3416166

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Feeding Problem (1850)

Event Date 03/19/2016

Event Type  malfunction  

Event Description

Kangaroo joey pump alarmed repeatedly with screen showing "code error" when bedtime feed was trying to be administered, despite repeated troubleshooting efforts to the entire feeding system by the skilled nurse providing client care.Client's feeding was delayed for 90 minutes until another pump was used to replace it.Diagnosis or reason for use: feeding problem.

• Brand Name: KANGAROO JOEY ENTERAL PUMP
• Type of Device: ENTERAL PUMP
• Manufacturer (Section D): COVIDIEN; 710 medtronic parkway; minneapolis MN 55432 5604
• MDR Report Key: 5546800
• MDR Text Key: 41956118
• Report Number: MW5061447
• Device Sequence Number: 1
• Product Code: LZH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/21/2016

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 Number: AMERICAN HOME PATIENT# 3416166
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 39