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

Catalog Number 4540018

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun (b)(4) internal report # (b)(4) as no sample and no picture was provided for investigation a malfunction could not be detected: the complaint is only taken to knowledge and filed for statistical purposes.Device history record (dhr): reviewed the dhr for batch 18g03ge271 there is no abnormality and no such defect detected at in process and at final control inspection.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

Event Description

As reported through notivisa(translation of user facility information by bbm sales organization in (b)(4)): damaged/product/over infusion notivisa is the computerized system for reporting complaints to anvisa, the national health surveillance agency in brazil.Through this system, all customer are able to proceed with any kind of complaint.Notivisa number: 2020.07.002303.As reported by the customer:"fluorouracil medicine that was made in the elastomeric infusion pump completed before the time.".

• Brand Name: EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, pa ; 2408332
• MDR Report Key: 10398460
• MDR Text Key: 202948131
• Report Number: 9610825-2020-00173
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Catalogue Number: 4540018
• Device Lot Number: 18G03GE271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1