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

Model Number	4540008-02
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun melsungen ag internal report (b)(4): the complaint is still under investigation.A follow-up report will be provided, as soon as investigation has been completed.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 or Problem Description
As reported by the user facility / translation of user facility information by bbm sales organization in (b)(4): "overinfusion" "easypump has been running for 17 hours instead of 48 hours.".
Additional Manufacturer Narrative
This report has been identified as b.Braun melsungen ag internal report (b)(4): received 1 used and filled easypump ii lt 100-50-s.The received sample was reported contaminated with cytotoxic drug.As received condition, clamp clip of received sample was clamped.Patient connector was connected to the red closing cone.Visual inspection had done throughout the sample.Crystallized residue was not observed on the received sample.Root cause analysis: the sample was sent for flow rate test.The flow rate deviation from nominal flow rate for complaint sample was -3.32% from nominal flow rate.The flow rate results was within specification ±15% deviation from nominal flow rate.There are some possibilities that can cause the sample empties faster than nominal time in actual application, such as one or combination factors of more than one 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 2ml/hr to 2.36ml/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 blow mold: folded blow mold will also 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.

• Brand Name: EASYPUMP II
• Common Device Name: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 12453622
• Report Number: 9610825-2021-00359
• Device Sequence Number: 3924683
• Product Code: MEB
• UDI-Device Identifier: 04046964448485
• UDI-Public: (01)04046964448485(17)250301(10)20C12GE221
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K081905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: 4540008-02
• Device Catalogue Number: 4540008
• Device Lot Number: 20G09GE261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1