MAUDE Adverse Event Report: MEDELA, INC.; PUMP, INFUSION, ENTERAL

Model Number 4100

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2019

Event Type  malfunction  

Event Description

Infant's gavage feeding started while being held skin to skin with mother.Upon rechecking infant 45min and 1.5 hrs later, noticed feeding pump lights on blinking and volume calculated correctly on screen.2.5hrs later, approached bedside to vent orogastric tube when feed was to be completed and found syringe plunger not engaged with pump, thusly no feed was given to infant.Pump plunger was not visualized due to venting orogastric tube reminder note covering such area.No alarms from pump of not administering feed was noted.Blood glucose check was performed and doctor aware of event.Parents at bedside also made aware of nurse error.

• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): MEDELA, INC.; 1101 corporate dr; mchenry IL 60050
• MDR Report Key: 9580456
• MDR Text Key: 174707227
• Report Number: 9580456
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/23/2019,12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2019
• Event Location: Other
• Date Report to Manufacturer: 01/13/2020
• Type of Device Usage: N
• Patient Sequence Number: 1