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

Lot Number #383400

Device Problems Defective Device (2588); Air/Gas in Device (4062)

Patient Problems Abdominal Pain (1685); Vomiting (2144); Sleep Dysfunction (2517)

Event Date 04/09/2018

Event Type  Injury  

Event Description

Vomiting; cardinal health notified us that the food pump and bags my son was using for at least a year were defective and could introduce air into the line.This resulted in frequent vomiting (often once or twice a day) and abdominal pain (poor sleeping).Fda safety report id# (b)(4).

• Brand Name: KANGAROO JOEY PUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 11900934
• MDR Text Key: 253558885
• Report Number: MW5101613
• 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: 05/26/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2019
• Device Lot Number: #383400
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 MO