MAUDE Adverse Event Report: B. BRAUN MEDICAL INDUSTRIES SDN. BHD EASYPUMP ELASTOMERIC DEVICE; PUMP, INFUSION, ELASTOMERIC

Model Number II LT 270-54-S

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 07/30/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 the pt's easy pump containing fluorouracil 1 g/20 ml was noted to be empty.It appeared that the easy pump infused the medication too quickly.The pt received the chemotherapy infusion on (b)(6) 2019 and it is supposed to be completed on (b)(6) 2019 at 15:30.Fda safety report id# (b)(4).

• Brand Name: EASYPUMP ELASTOMERIC DEVICE
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MEDICAL INDUSTRIES SDN. BHD
• MDR Report Key: 8907468
• MDR Text Key: 155008648
• Report Number: MW5089152
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/14/2019

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 Expiration Date: 03/01/2024
• Device Model Number: II LT 270-54-S
• Device Catalogue Number: 4540018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2019
• 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