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)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported the pump seemed to be working fine for the first 10 minutes and then it 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.
Additional Manufacturer Narrative
H4 device manufacture date was added.The device history record (dhr) for lot 210320045 was reviewed and no anomalies related to the reported issue were observed.Five pictures were visually inspected; however, it was not possible to identify if the sample met the quality acceptance criteria through the pictures.One sample was received, and testing was performed.The reported condition could be confirmed.A root cause could not be determined with the available information.No action plan is required at this time.Staff were notified of the reported event.We will continue to monitor related reports to determine if additional actions are necessary.

• 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: 20863730
• Report Number: 1423537-2024-00334
• Device Sequence Number: 8839320
• Product Code: LZH
• UDI-Device Identifier: 10884521190825
• UDI-Public: (01)10884521190825(17)240131(10)210320045
• 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,Followup
• Report Date (Section B): 01/03/2025

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 Expiration Date: 01/31/2024
• Device Model Number: 77100FD
• Device Catalogue Number: 77100FD
• Device Lot Number: 210320045
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown