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

Catalog Number 4540018-02

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/27/2018

Event Type  malfunction  

Event Description

During preparation of a fluorouracil continuous infusion using b.Braun easypump, compounding iv tech noted that the elastomeric device started to leak.Iv tech halted prep.Event abated after use stopped or dose reduced? yes.Route: intravenous.Therapy date: (b)(6) 2018.

• Brand Name: EASYPUMP ELASTOMERIC INFUSION PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.
• MDR Report Key: 8119528
• MDR Text Key: 129150928
• Report Number: MW5081726
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: 4540018-02
• Device Lot Number: 17E08GE581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 58