MAUDE Adverse Event Report: Cardinal Health Kangaroo; Pump, Infusion, Enteral

Model Number	BSPFD
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction

• Brand Name: Kangaroo
• Common Device Name: Pump, Infusion, Enteral
• Manufacturer (Section D): Cardinal Health; 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 ; +1(508)618-3640
• MDR Report Key: 50610049
• Report Number: 1423537-2026-00276
• Device Sequence Number: 10634878
• Product Code: LZH
• UDI-Device Identifier: 10192253068900
• UDI-Public: (01)10192253068900(17)301031(10)2527624164
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: BSPFD
• Device Catalogue Number: BSPFD
• Device Lot Number: 2527624164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/18/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown