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

Catalog Number 4540003-07

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Discomfort (2330)

Event Date 02/02/2024

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: the 500ml of spasfon debridat et primperan passed much more quickly than the advertised flow rate.Difficult assessment on the night of (b)(6) to (b)(6) but connection on (b)(6) at 7:30 a.M.And end of broadcast on (b)(6) 2024 at 11 a.M.

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.The flow rate report of affected batch 23k01ged11 was reviewed.For final control flow rate (after eto) report, the average flow rate deviation from the nominal flow rate was between -7.72% and 7.49%.Received 1 used and filled easypump ii lt 500-12.5-s-eu/sa.As received condition, the clamp clip of received sample was clamped, and no wing cap was connected to the patient connector.The sample was decontaminated and sent for flow rate test ((b)(6)).The flow rate deviation from nominal flow rate for received sample was 11.02%.The flow rate of received sample was within the specification ±15% deviation from nominal flow rate.The received sample was further investigated to confirm the flow rate performance.The received sample was dissected into sub pump and flow restrictor.The dissected parts were assembled in new sub pump and new flow restrictor.All samples were within flow rate specification.Figure 4: flow rate results."the product passed much more quickly than the advertised flow rate" as per customer description was not observed at the sub pump and flow restrictor of received sample.Fast flow rate was observed during bbm investigation.During bbm investigation, the decisive value to evaluate the flow rate will be measured approx.At half of the pump total infusion time.Bbm only tested the flow rate at the first 6hours of the infusion time.According to the flow rate pattern of easypump, the initial flow rate will be higher than nominal flow rate.The volume collected for the first 6hours will be higher as initial flow rate is higher.By comparing the flow rate test from bbm investigation and bmi investigation, there is no significant difference of the volume delivered between bbm investigation and bmi investigation over the time 1hour, 2 hours, 3 hours, and 6 hours.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 determine.The flow rate of received sample was within the specification after sent for flow rate test, which is according to test method 116008 under lab condition.Justification: not confirmed.

• Brand Name: EASYPUMP® II
• 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 ; 4847197287
• MDR Report Key: 18823546
• MDR Text Key: 337745186
• Report Number: 9610825-2024-00147
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 03/03/2024

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 Catalogue Number: 4540003-07
• Device Lot Number: 23K01GED11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2024
• Date Device Manufactured: 08/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1