MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP II; ELASTOMERIC INFUSION PUMP

Model Number 270 ML X 5 ML/HR

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem Chemical Exposure (2570)

Event Date 01/17/2023

Event Type  malfunction  

Event Description

According to the patient, the spike which gets inserted into the easypump became disconnected and the chemo spilled onto his clothes.Per nurse from the chemo clinic, this is the second time that this has happened for this patient.

• Brand Name: EASYPUMP II
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 16313077
• MDR Text Key: 309093041
• Report Number: MW5114750
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 270 ML X 5 ML/HR
• Device Lot Number: 4540018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male