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	06/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility / translation of user facility information by bbm sales organization in australia: "overinfusion" reason of complaint: pump ran empty after 13 hours.Pump filled with ceftiaxone to infuse over 24 hours.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun melsungen ag internal report # (b)(4).Sample evaluation: received one sample of easypump ii lt 270-27-s without original packaging.The batch number on the big bottom cap of the sample was 21h14ge221.Upon receipt, no solution was found in the sample and observed the outer sleeve of the used sample was found to be folded.Flow rate test: the sample was unfolded and decontaminated.Then, the sample was sent for flow rate test.Results: the flow rate deviation from nominal flow rate was 0.79%.The flow rate was within the specification of ±15% deviation from nominal flow rate.Folded outer shell was observed upon receipt of sample.According to ifu version 4.0, the outer layer has to be unfolded properly prior filling.Folded outer shell will act as an external pressure to elastomeric membrane and increase the flow rate of the product.Hence, the fast flow rate observed by customer is highly possible due to the folded outer sleeve.Besides that, there are possibilities that may cause fast flow rate to occur during application under one or combination of the following factors listed 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 10ml/hr to 11.8ml/hr.Refer to ifu under precautions/cautions: temperature dependency.Factor 2: external pressure external pressure such as squeezing or laying on the pump will increase the flow rate which causes the pump to empty earlier than the nominal time.Conclusion: folded outer shell was observed on the complaint sample and the complained on fast flow rate is highly possible due to the folded blow mold which act as external pressure to the elastomeric membrane.Device history record (dhr): reviewed the dhr for batch 21h14ge221, there is no such defect detected at in process and at final control inspection pertaining fast flow rate.Complaint is not confirmed.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
• 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
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 14960905
• Report Number: 9610825-2022-00269
• Device Sequence Number: 7045506
• Product Code: MEB
• UDI-Device Identifier: 04046964448485
• UDI-Public: (01)04046964448485(17)260801(10)21H14GE221
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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 Expiration Date: 08/01/2022
• Device Model Number: 4540008-02
• Device Catalogue Number: 4540008
• Device Lot Number: 21H14GE221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown