MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD ENTRAFLOH2O FEEDING PUMP; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number ENTRAFLOH2O

Device Problems Crack (1135); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2023

Event Type  malfunction  

Event Description

We have been experiencing a high failure rate of medline entrafloh2o feeding pumps, related to the pump's iv(intravenous) pole clamps being overtightened since the pumps are not holding on the iv poles securely.This causes the following problems: pumps that are not tightened properly can slip or fall, leading to damage to the pump, staff and/or patients.When staff are attempting to properly secure the pumps to the iv poles and they over tighten the iv pole clamp, the rear housing of the pumps crack, exposing the pump to liquid ingress and possible falling of the pump.

• Brand Name: ENTRAFLOH2O FEEDING PUMP
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 16940721
• MDR Text Key: 315386637
• Report Number: MW5117567
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENTRAFLOH2O
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other