MAUDE Adverse Event Report: CARDINAL HEALTH EPUMP FEED AND 1000MLFLUSH SET; PUMP, INFUSION, ENTERAL

Model Number	773662
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
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 the nurses have been having issues with the kangaroo pumps alarming and filling with air in the tubing.This has occurred throughout the past two weeks.After observation and not having success with kangaroo pump changes, it looks as though the issue may be with the kangaroo epump set with the flush bag.The issue occurring is that the pump will alarm with a flow error and staff will then re-prime the bag and the pump will still continue to alarm with the same error message.The other significant issue is that tubing is somehow filling with air on the side closest to the patient.The air in line alarm only occurs if the air develops before the motor wheel, so this means after the motor wheel the tubing is filling with air.This could negatively affect their population with duodenal tubes by putting air in the bowel, and its easy to miss as this error will not trigger a pump alarm.
Additional Manufacturer Narrative
A decontaminated sample was received at the plant for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual and functional evaluation of the sample, the defect was unconfirmed.A corrective action is not applicable at this time.

• Brand Name: EPUMP FEED AND 1000MLFLUSH SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17738069
• Report Number: 9612030-2023-03825
• Device Sequence Number: 6615248
• Product Code: LZH
• UDI-Device Identifier: 10192253009958
• UDI-Public: 10192253009958
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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): 01/30/2024

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: 773662
• Device Catalogue Number: 773662
• Device Lot Number: 2300501864
• 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: 08/24/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown