MAUDE Adverse Event Report: CARDINAL HEALTH EPUMP 1000ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number	773656
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
Customer reports: the pump pulled air into the line.The formula was in front and behind the air pocket and the pump did not alarm.The patient has been having issues with gas and an x-ray showed a large gas burden, unsure if it is related to pump previously pulling air into line and staff not noticing.

• Brand Name: EPUMP 1000ML PUMP SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12436538
• Report Number: 1282497-2021-10595
• Device Sequence Number: 3421072
• Product Code: LZH
• UDI-Device Identifier: 10884521022096
• UDI-Public: 10884521022096
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2021

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
• Operator of Device: No Information
• Device Model Number: 773656
• Device Catalogue Number: 773656
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/07/2021
• Patient Sequence Number: 1