MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KANGAROO; PUMP, INFUSION, ENTERAL

Model Number	BSPFF
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
Event or Problem Description
The customer reported the pump seems overly sensitive to even small bubbles in the tubing before the cartridge, causing the pump to stop feeding.This can be problematic as it disrupts the continuous feeding process.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record for the affected lot was reviewed, showing that manufacturing and inspection of product was performed as per applicable procedures and validated process.No sample was available for evaluation; however, two pictures were provided that showed the primary packaging of the reported product code, and the formula used during the feed administration.These pictures were not enough to identify if the device meet with the quality acceptance criteria.The root cause could not be determined.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 200, LLC; 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: 21686883
• Report Number: 1423537-2025-00138
• Device Sequence Number: 21159184
• Product Code: LZH
• UDI-Device Identifier: 10885380177156
• UDI-Public: (01)10885380177156(17)291231(10)2500209964
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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 Model Number: BSPFF
• Device Catalogue Number: BSPFF
• Device Lot Number: 2500209964
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown