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

Model Number 773656

Device Problem Air/Gas in Device (4062)

Patient Problems Abdominal Distention (2601); Insufficient Information (4580)

Event Date 06/04/2021

Event Type  malfunction  

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 Description

Customer reports: the kangaroo bag that air is continuously getting into the line when running on the pump.

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
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11958200
• MDR Text Key: 258749921
• Report Number: 1282497-2021-10242
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521022096
• UDI-Public: 10884521022096
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 773656
• Device Catalogue Number: 773656
• Device Lot Number: 201180072
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/04/2021
• Patient Sequence Number: 1