MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. EASYPUMP ELASTOMERIC INFUSION PUMP; PUMP, INFUSION, ELASTOMERIC

Model Number 4540052-02

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 02/06/2023

Event Type  malfunction  

Event Description

During compounding in easypump 400ml - 200ml/hr size started leaking where the tubing connects to the easypump.Pump was discarded during compounding process.

• Brand Name: EASYPUMP ELASTOMERIC INFUSION PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; bethlehem PA 18018 3524
• MDR Report Key: 16380494
• MDR Text Key: 309768997
• Report Number: MW5114957
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/10/2023

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 Operator: Health Professional
• Device Model Number: 4540052-02
• Device Catalogue Number: 4540052-02
• Device Lot Number: 22H15GE731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1