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

Model Number	E10FDR
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
D4 unique identifier (udi) # was updated to include the expiration date.D4 expiration date was added.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported they needed to pull on the bag to hold it straight during priming otherwise there was a gap of air that occurs and doesn't readily move through the tubing.The bottom where the tubing meets the bag wasn't twisted when she changed the bag saturday vs the bag, she had used prior.It did tend to bunch up a bit but did not cause any alarms.She didn't attempt to put the bag in a backpack as that seems to cause the pump to alarm.Additional information received stated the air gap was not in the bag.The formula did prime through the tube but there was a gap of air, and the formula primed around it.The bottom of the bag is twisting and bunching up.
Additional Manufacturer Narrative
The device history record review was conducted for the reported lot and there were no issues noted during the manufacturing of this lot.There were no physical samples received for investigation, but a video was provided.The video was reviewed, and the reported condition was able to be observed.The root cause could not be determined without the physical sample.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
• 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: 21228829
• Report Number: 1423537-2025-00046
• Device Sequence Number: 8341507
• Product Code: LZH
• UDI-Device Identifier: 10885380177392
• UDI-Public: (01)10885380177392(17)260531(10)2316305764
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K221603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2025

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: 05/31/2026
• Device Model Number: E10FDR
• Device Catalogue Number: E10FDR
• Device Lot Number: 2316305764
• 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: 12/31/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 01/28/2025; 01/31/2025
• Date Device Manufactured: 07/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown