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

Model Number	E5FDR
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
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that a health care professional (hcp) at the resource exchange in colorado springs, co who sees pediatric outpatients on home enteral nutrition was told by an unknown source to use iddsi level 1 with the kangaroo omni enteral feeding pump thick formula feeding sets so she was advising a couple of families to dilute commercial blenderized tube feeding (btf) formulas down to iddsi 1 with water and in doing so, the families experienced omni pump alarms.They are not sure what type of alarm, but it was reported to them as either "clogged feeding tube" or "air bubbles¿.They are not sure what specific formula they used or if modulars were used, or if the formula was homogenous without lumps or chunks but when they tried a level 2, the thick formula feeding sets worked fine as the pump and thick feeding sets were designed to do.There was no patient harm.Additional information was received stating the kangaroo omni pump with thick formula feeding sets had trouble with iddsi level 1 showing the alarm ¿patient tube block¿ but when the formula was switched to a level 2 iddsi formula ¿ the same pump worked fine.Air bubbles were observed, especially with thinner mixtures.The formula used was real food blends from nutricia.The method of delivery was a g-tube.
Additional Manufacturer Narrative
The device history record (dhr) review for the lot reported revealed no issues identified related to the reported event.The lot passed all the required in-process verification activities.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.There were no samples or pictures provided for evaluation; therefore, a root cause could not be determined.Staff were notified of the reported condition to raise staff awareness.We will continue to monitor, and this information will be used for further tracking and trending purposes.

• 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: 20406579
• Report Number: 1423537-2024-00205
• Device Sequence Number: 6545941
• Product Code: LZH
• UDI-Device Identifier: 10885380177415
• UDI-Public: (01)10885380177415(17)260630(10)2318519264
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K221603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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: E5FDR
• Device Catalogue Number: E5FDR
• Device Lot Number: 2318519264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/25/2024
• Date Device Manufactured: 07/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown