MAUDE Adverse Event Report: CARDINAL HEALTH CONNECT FEED STE 1000ML NS; PUMP, INFUSION, ENTERAL

Model Number	77100FD
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
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 in the evening they connected an enteral feeding bag to the pump, hit auto prime and came back to the pump to find that all formula past the cassette had leaked onto the floor leaving the tubing full of air.They then held to prime and placed the cap on the end of the tubing.When they came back to the feeding pump the feed had again exited the tubing.Assuming this was operator error, they held to prime again to clear the air and immediately connected the primed tubing to the patient's j-tube.While attached (prior to starting the feeds) the feed began gravity feeding into the patient leaving air in the tubing between the cassette and the patient.The customer stated that they then gave up, sequestered the bag and re-primed a different bag (the old style with the adapter on the end).Zero issues occurred with the new bag, which makes them believe it was a bag error and not a pump/operator error.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One used sample was received for evaluation.Visual and functional inspection was performed and found that one line detached from the cassette.A corrective and preventive action has been initiated to address the reported issue.All information received will be used for further tracking and trending purposes.

• Brand Name: CONNECT FEED STE 1000ML NS
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16629119
• Report Number: 1282497-2023-10747
• Device Sequence Number: 20164456
• Product Code: LZH
• UDI-Device Identifier: 10884521190825
• UDI-Public: 10884521190825
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/18/2023

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: 77100FD
• Device Catalogue Number: 77100FD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Sex: Female