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

Catalog Number 4540008-07

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).The complaint is under evaluation.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

As reported by the user facility (translation of user facility information by bbm sales organization in france: "overinfusion" according to the cusomer: "the infusion does not last 24 hours.The nurse had to change it at 11.30 a.M.When she put it in at 6 p.M.The day before (incident 2 days in a row)".

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report # (b)(4).Root cause analysis: sample/s evaluation: the flow rate report of affected batch 22e12ged41 was reviewed.For final control flow rate (after eto) report, the average flow rate deviation from the nominal flow rate was between 4.80% and 10.61%.Received 10 easypump ii lt 270-27-s.7 pieces of the sample are in the original packaging and 3 pieces more are used and without original packaging.As received condition, the clamp clips of 3 used samples were clamped, and wing caps were connected to the patient connector.Visual inspection had done throughout the sample.No abnormality was detected through the inspection.The sample was sent for flow rate test (ltca-cqk8ls).The flow rate of received samples were within the specification ±15% deviation from nominal flow rate.However, there are some possibilities that to cause the fast flow rate to occur during application, such that one or combination factors are listed as below: factor 1: temperature: the temperature of the surrounding will affect the flow rate of the sample.For every increase of 1°c, the flow rate of the sample will increase approximately by 3%.For example, if the flow restrictor of the product reaches the temperature of 37°c, the flow rate of the sample will increase by approximately 18% which means the flow rate will increase from 10 ml/hr to 11.8 ml/hr.Factor 2: external pressure external pressure such as squeezing or laying on the pump will increase the flow rate which cause the pump to empty earlier than the nominal time.Simulation of external pressure had been conducted.The flow rate of the product can increase when external force is applied to the pump.However, this external force is against the intended use of the product according to ifu.Factor 3: folded outer shell according to ifu, the outer layer must be unfolded properly prior filling.Folded outer shell will act as the external pressure to elastomeric membrane and increase the flow rate of the product.Summary of root cause analysis: since the flow rate of received samples were within the specification, we considered this complaint as not confirmed.The flow rate of received samples were within the specification after sent for flow rate test, which is according to test method under lab condition.

• Brand Name: EASYPUMP II
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-strasse 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 ; 4847197287
• MDR Report Key: 18085617
• MDR Text Key: 327553398
• Report Number: 9610825-2023-00085
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062700
• 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: 11/07/2023

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 Catalogue Number: 4540008-07
• Device Lot Number: 22E12GED41
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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