MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; PUMP,FEEDING,ENTRAFLO H20,PURCHASE

Catalog Number	ENT199255
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	Feeding Problem (1850)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported, "the issue started with the water not flushing thru it however, it would continue to run.Now, the machine is not working at all." it has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
The customer reported, "the issue started with the water not flushing thru it however, it would continue to run.Now, the machine is not working at all.".

• Brand Name: MEDLINE
• Common Device Name: PUMP,FEEDING,ENTRAFLO H20,PURCHASE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer (Section G): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: brooke jantzen ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24808046
• Report Number: 1417592-2026-00378
• Device Sequence Number: 9620733
• Product Code: LZH
• UDI-Device Identifier: 10888277420052
• UDI-Public: 10888277420052
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K940555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ENT199255
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 26 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White