MAUDE Adverse Event Report: COVIDIEN LLC COVIDIEN JOEY KANGAROO; JOEY KANGAROO PUMP

Model Number SMF0211-085

Device Problems Improper Flow or Infusion (2954); Pumping Problem (3016)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/02/2016

Event Type  Injury  

Event Description

A (b)(6) infant with history of cardiac anomaly, prematurity, reflux, and possible gastrointestinal motility issues required continuous tube feeds via a gastric feeding tube.While the continuous tube feeds were in progress via the covidien joey kangaroo pump, it was identified by the nurse the feeding pump was removing formula and medication from the patient's stomach as evidenced by the red colored tylenol noticed in the kangaroo bag tubing.The nurse attempted to use a different bag but when she changed it, the pump repeated the same issue.A new covidien joey kangaroo pump, tubing, and bag obtained.No further issues identified.No patient harm noted.Tube feeds continued without issue.Dose or amount: 137ml/kg/day.Frequency: continuous.Route: feeding tube.Dates of use: 02/01/2016.Is the product compounded: no.Is the product over-the-counter: no.Event abated after use stopped or dose reduced: yes.

• Brand Name: COVIDIEN JOEY KANGAROO
• Type of Device: JOEY KANGAROO PUMP
• Manufacturer (Section D): COVIDIEN LLC; mansfield MA
• MDR Report Key: 5489935
• MDR Text Key: 40053630
• Report Number: MW5060800
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMF0211-085
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/03/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 MO
• Patient Weight: 5