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 Codes	Abdominal Distention (2601); Insufficient Information (4580)
Date of Event	06/04/2021
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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
Customer reports: the kangaroo bag that air is continuously getting into the line when running on the pump.
Additional Manufacturer Narrative
H3 evaluation summary: the device history record (dhr) was reviewed and shows evidence that the product was released according to all established procedures and quality documentation.One used sample was received at the manufacturing site for evaluation.Visual and functional inspection was performed, and no failure was found.No root cause could be found related to the manufacturing/production process.The root cause could not be determined as the device functioned as expected.No formal investigation action is being taken since the failure mode could not be confirmed related to the manufacturing/production process.This complaint will be used for tracking and trending purposes.

• 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: 11958200
• Report Number: 1282497-2021-10242
• Device Sequence Number: 4765714
• Product Code: LZH
• UDI-Device Identifier: 10884521022096
• UDI-Public: 10884521022096
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 10/12/2021

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
• Device Lot Number: 201180072
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 10/12/2021
• Patient Sequence Number: 1