MAUDE Adverse Event Report: CARDINAL HEALTH EPUMP 500ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number	772055
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
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 stated that when the pump gets to 10ml or 15ml, the pump is still going, but it's passing lots of air and causing air to go into the patient.The mother tried several of the bags and the issue continued to happen.They originally thought it was due to the pumps, however they diagnosed the pumps and confirmed with their tech that it was the bags.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event as no samples were returned for evaluation and the device history record was reviewed indicating that the product was released accomplishing all quality standards.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: EPUMP 500ML PUMP SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18903159
• Report Number: 3009211636-2024-00800
• Device Sequence Number: 7919376
• Product Code: LZH
• UDI-Device Identifier: 10192253009903
• UDI-Public: 10192253009903
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/28/2024

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: 772055
• Device Catalogue Number: 772055
• Device Lot Number: 2327200357
• 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: 02/16/2024
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 03/28/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown