MAUDE Adverse Event Report: CARDINAL HEALTH KANGAROO JOEY ENTERAL FEED PUMP ACCUSYSTEM; PUMP, INFUSION, ENTERAL

Model Number SMF0211-068

Device Problem Defective Device (2588)

Patient Problems Abdominal Pain (1685); Vomiting (2144); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/03/2021

Event Type  Injury  

Event Description

We were notified that the pump bags our daughter uses with her gtube pump have been defective.They have been causing her to gag, vomit, have abdominal pain unexplainably until now.She has been sent home from school, missed family outings and has lost weight as a result.Fda safety report id # (b)(4).

• Brand Name: KANGAROO JOEY ENTERAL FEED PUMP ACCUSYSTEM
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 11633700
• MDR Text Key: 244659681
• Report Number: MW5100637
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SMF0211-068
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 10 YR
• Patient Weight: 28