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

Model Number II LT 270-54-S

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 07/29/2019

Event Type  Injury  

Event Description

Home pump / elastomeric device discharged approx 24 hours too soon.Pump full of fluorouracil.Elastomeric device discharged too quickly.Dose or amount: 5-fu 4248mg/241ml ns; frequency: over 46 hrs, route: iv.Dates of use: (b)(6) 2019.Diagnosis or reason for use: malignant neoplasm of colon.

• Brand Name: B. BRAUN EASY PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 8912335
• MDR Text Key: 155547977
• Report Number: MW5089185
• 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: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: II LT 270-54-S
• Device Catalogue Number: 4540018-02
• Device Lot Number: 19C13GE561
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/09/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR
• Patient Weight: 51