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

Model Number N/A

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 11/10/2022

Event Type  malfunction  

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in saudi arabia: "overinfusion".According to the customer: "10 patients received folfox ( 5-fu ) for planned 48 hrs as part of crc protocol, they return to hospital after ( 20-24 ) hrs after start of infusion, the pump that used is (easypump || lt 400-80-s ) and the fill volume was 250 ml.No adverse reactions happened".

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.

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (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: received 1 used and filled easypump ii lt 400-80-s.Since the sample is received in original packaging, the received sample is reference sample.As received condition, the clamp clip of received sample was clamped, and wing cap was connected to the patient connector.Visual inspection had done throughout the received sample.The big top cap of the received sample was broken.This could happen during the transportation.The sample was sent for flow rate test (ltca-cnnvxq).The flow rate deviation from nominal flow rate for received sample was -0.11%.The flow rate of received sample was 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 5ml/hr to 5.9ml/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: folder outer shell.Folded outer shell was observed during investigation.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 (reference sample) was within the specification, we considered this complaint as not confirmed.The flow rate report of affected batch 22a03ge291 was reviewed.The average flow rate deviation from the nominal flow rate was between -8.84% and -2.51%.Justification: not confirmed.

• 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 ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15966203
• MDR Text Key: 308130523
• Report Number: 9610825-2022-00520
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K062700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4540016-07
• Device Lot Number: 22A03GE291
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2019
• 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