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

Catalog Number	4540003-07
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	02/01/2024
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 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 or Problem 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) 2024 at 7:30 a.M.And end of broadcast on (b)(6) 2024 at 11 a.M.
Additional 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.Sample/s evaluation: final control flow rate report of affected batch 23d15ged11 was reviewed.For final control flow rate report, the average flow rate deviation from the nominal flow rate was between 0.08% and 7.76%.No abnormality was observed.Received 1 piece of used easypump ii lt 500-12.5-s-eu/sa.As received condition, clamp clip of the received sample was clamped, and the wing cap was not attached to the patient connector.No abnormalities were found on the sample during visual inspection.The sample was decontaminated and sent for flow rate test (etr no.: 20240321_2013).The flow rate deviation from nominal flow rate for received sample was -4.27%.The flow rate of received sample was within the specification of ±15% deviation from nominal flow rate.Fast flow rate at the pump as described by the customer was not observed at the received sample.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 40 ml/hr to 47.2 ml/hr.Factor 2 folded outer shell (outer layer) folded outer shell (outer layer) will also act as the external pressure to elastomeric membrane and increase the flow rate of the product.Factor 3 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.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
• Common Device Name: 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 ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18823548
• Report Number: 9610825-2024-00146
• Device Sequence Number: 14214905
• Product Code: MEB
• UDI-Device Identifier: 04046964448515
• UDI-Public: (01)04046964448515
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 4540003-07
• Device Lot Number: 23D15GED11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2024
• Supplement Report FDA Received Date: 06/03/2024
• Date Device Manufactured: 08/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown