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

Catalog Number 4540050-02

Device Problems Fluid/Blood Leak (1250); Defective Component (2292)

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

Event Date 03/07/2023

Event Type  malfunction  

Event Description

No patient involvement.Defective lot number of b braun easypump 250ml/ 175ml/hr.Lot 22k05ge722; ref 4540050-02.Easypump leaking after filling with sodium chloride 0.9%.Leaking from tubing insertion into top of pump.

• Brand Name: EASY PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.
• MDR Report Key: 16513224
• MDR Text Key: 311045706
• Report Number: MW5115593
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• 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: 03/07/2023

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: Lay User/Patient
• Device Catalogue Number: 4540050-02
• Device Lot Number: 22K05GE722
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose