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

Catalog Number 4540014-07

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 06/16/2023

Event Type  malfunction  

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in austria: "overinfusion." according to the cusomer: "easypump with the filling volume 400 ml finished a few hours earlier.According to the plan, the end of the runtime would have been at 7.30 a.M.- in fact the empty pump was found at 5.30 p.M.The day before.Volume 400 ml flow 10/h time: 40 h.Administered drug: 5-fu cytostatic.According to the responsible physician, there was no negative impairment of the patient.".

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.

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report # (b)(4).Sample/s evaluation: final control flow rate report of affected batch 22a31ged71 was reviewed.For final control flow rate report, the average flow rate deviation from nominal flow rate was between (b)(4).Received 1 used and filled easypump ii lt 400-40-s.As received condition, the clamp clip of the sample was clamped, patient connector was not connected to wing cap.Visual inspection had done throughout the sample.No abnormality was detected through the inspection.The sample was then decontaminated and sent for flow rate test (etr no:ltca-cu6asa).The flow rate deviation from nominal flow rate for received sample was (b)(4).The flow rate of received sample was within the specification (b)(4) 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 (b)(4).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 (b)(4) which means the flow rate will increase from (b)(4).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 sample was within the specification, hence we considered this complaint as not confirmed.Cause: cause could not be determined.The flow rate of received sample was within the specification after sent for flow rate test, which is according to test method under lab condition.Justification: not confirmed.Device history record (dhr): reviewed the dhr for batch 22a31ged71, 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.

• 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: 17290421
• MDR Text Key: 319020077
• Report Number: 9610825-2023-00331
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4540014-07
• Device Lot Number: 22A31GED71
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• 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