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

Catalog Number 4540018

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun (b)(4) internal report # (b)(4).All available information has been forwarded to the actual manufacturer.If the sample and/or additional pertinent information becomes available, a follow up report will be filed.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 by the user facility (translation of user facility information by bbm sales organization in (b)(6)): overinfusion.When did the failure occur: error out-of-box;during therapy.Easy-pump model 4540018 pump used for protocol management 5fu ends early.Fill volume 230 ml (not including vol max retention).Start filling with 0.9% sf for pump priming, continue with the amount of sf needed for the dilution and at the end they place the drug.They use 5fu sandoz brand of 1g or 5 g, close clamp and they bag the device to be connected to the patient the same day.Patients report that it passes faster than it should by finishing the administration at the 30th hour instead of the 46th hour they had calculated.Patients use a pump outside of bed when sleeping, have indications not to place it in height because of the risk of hanging.City cold, houses with a lot of heating.They report to always put the pump near the catheter.Rural patients commonly use wood-burning stoves, spend the day close to the heat.

• Brand Name: EASYPUMP
• Type of Device: ELASTOMERIC INFUSION PUMP
• 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 18109 ; 4842408332
• MDR Report Key: 10612481
• MDR Text Key: 209373011
• Report Number: 9610825-2020-00227
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: CI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4540018
• Device Lot Number: 20C21GE271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2020
• 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