MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG EASYPUMP 2; ELASTOMERIC PUMPS

Model Number 4540018-07

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are available.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

According to the complainant the drug was administrated in a shorter period than expected no patient complications were reported as a result of this event.

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).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.Root cause analysis: sample/s evaluation: the flow rate report of affected batch 22n24ged91 was reviewed.For final control flow rate (after eto) report, the average flow rate deviation from the nominal flow rate was between -3.30% and 2.09%.Received 1 used easypump ii lt 270-54-s-eu/sa.As received condition, the clamp clip of received sample was clamped, and red combi stopper was connected to the patient connector.The received sample was weighed and recorded at 76.80 g.The average weight of an unfilled easypump for this article is 75g and the retained volume should be [?]8g.This deduces that the received sample has emptied.Visual inspection had done throughout the received sample.No crack and crystallization were observed at received sample.Then, the sample was sent for decontamination process.During decontamination process, leaking at filter air vent was observed at the received sample.The leak filter was then replaced with the new filter and sent for flow rate test (202405132893).The flow rate deviation from nominal flow rate for received sample was -4.43%.The flow rate of received sample was within the specification ±15% deviation from nominal flow rate.The flow rate of the received sample was within specification after the leaked filter was replaced.The fast flow observed by the customer could be due to filter leakage which caused the drug being administrated in a shorter period.Leak at filter air vent is a known issue and will be addressed in an approved project.Summary of root cause analysis: leak at filter air vent was observed at received sample.The flow rate of received sample was within the specification after the filter was replaced with new filter.The drug was administrated in a shorter period than expected as per customer description was potentially due to leak at filter air vent.Hence, we considered this complaint as confirmed.

• Brand Name: EASYPUMP 2
• Type of Device: ELASTOMERIC PUMPS
• 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, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 19166782
• MDR Text Key: 341673935
• Report Number: 9610825-2024-00316
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2024

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: Health Professional
• Device Model Number: 4540018-07
• Device Lot Number: 22N24GED91
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1