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

Model Number 4540008-02

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

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

Event Date 01/31/2023

Event Type  malfunction  

Event Description

Easypump lt 270ml, 10ml/hr product code 4540008 by b braun - patient reports the tubing of the easypump elastomeric device was spilt and medication leaked out of the device near where the tubing exits the elastomeric.

• Brand Name: EASYPUMP LT ELASTOMERIC
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 16399222
• MDR Text Key: 309911486
• Report Number: MW5115026
• 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: 02/15/2023

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 Model Number: 4540008-02
• Device Catalogue Number: 4540008-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 127 KG
• Patient Race: White