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

Model Number	775100
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
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 there was an ongoing issue with the tube feed tubing pulling air into the line shortly after starting the feed.The patient is on bolus feeds and stated this issue happened with every feed.The tubing would initially prime, then when the feed was started it would immediately pull air.When trying to reprime, they could see it pulling air into the tubing despite the feed container being new and full.Three pumps were used, but the issue persisted.They used a different tubing set that contained 2 bags and poured the feed into the bag versus spiking the feed container.This solved the issue.
Additional Manufacturer Narrative
H 4 device manufacture date was added.The device history record (dhr) review showed all acceptance criteria inspections were within acceptable limits during the production process.A sample analysis could not be performed because no photograph was available, and the device had been disposed of by the customer.The reported condition could not be confirmed.Based on the present information, a root cause could not be determined, and an action plan is not required at this time.Staff were notified of the reported condition, to raise awareness.This complaint will be used for tracking and trending purposes.

• 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: 20303685
• Report Number: 1423537-2024-00167
• Device Sequence Number: 20764827
• Product Code: LZH
• UDI-Device Identifier: 10884521155817
• UDI-Public: (01)10884521155817(17)280229(10)240780005
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K040196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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: 775100
• Device Catalogue Number: 775100
• Device Lot Number: 240780005
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 11/04/2024
• Date Device Manufactured: 03/21/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown