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

Model Number	77100FD
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because no lot number was available.The sample was discarded; therefore, a sample evaluation could not be performed.Controls are in place that help to identify deviations and conditions in the feed tubing set that could led to the reported failure.The current manufacturing activities are running according to product specifications, meeting quality acceptance criteria, validation process, and released procedures.An action plan is not required currently.The manufacturing site will continue to monitor customer complaints and feedback notifications for adverse trends that require immediate attention.
Event or Problem Description
The customer reported the pump started ringing, stopped, and signaled a blockage.The customer didn't see any obstructions in the disposable feeding set.They noticed that many tiny air bubbles were forming in the liquid in the tube at the pump "impellers" that move the liquid through the cassette.

• Brand Name: KANGAROO
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20863799
• Report Number: 1423537-2024-00335
• Device Sequence Number: 8785914
• Product Code: LZH
• UDI-Device Identifier: 10884521190825
• UDI-Public: (01)10884521190825
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 12/06/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown