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

Model Number 77100FD

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2023

Event Type  malfunction  

Event Description

This rn went into room after shift report to check on patient and feeding pump connections.This rn noticed large air bubble coming from cannister, which measured 99 cm (26 inches) and a second air bubble at the base of the tube towards patient, which measured 12 cm (4 3/4 inches).This rn stopped feeding pump, obtained new equipment and feeding bag and started set-up with new equipment.This rn updated leaving evening rn found defect in bag.She did mention that she noticed and air bubble earlier and reprimed the line.This rn told her of previous experience and the steps to be taken if she encounters this situation again.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 16395872
• MDR Text Key: 309745093
• Report Number: 16395872
• 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: 02/06/2023

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 Model Number: 77100FD
• Device Catalogue Number: 77100FD
• 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: 02/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5840 DA
• Patient Sex: Male