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	04/11/2022
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 (b)(6): "infused too fast"."reason of complaint: we have had an easypump returned to us as it was completely infused over 12 hours rather than 24 hours.Benzylpencillin 10.8g in 240ml.".
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun melsungen ag internal report # (b)(4).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.Sample evaluation: received 1 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, there was no solution.It was reported the pump was filled with benzylpencillin.The pump was still in folded condition.Flow rate test: the sample was unfolded and then sent for flow rate test.Result: the flow rate deviation from nominal flow rate was -9.51%.The sample is within the specification ±15% deviation from nominal flow rate.According to ifu, the outer layer must be unfolded properly prior to filling.Folded outer shell will act as an external pressure to elastomeric membrane and increase the flow rate.Hence, the fast flow rate observed by customer is highly possible because the sleeve was not unfolded.Conclusion: the returned complaint sample was subjected to flow rate test and fast flow was not observed.The result was within specification.Complaint is 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 ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 14336868
• Report Number: 9610825-2022-00155
• Device Sequence Number: 17706254
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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: 08/01/2026
• Device Model Number: 4540008-02
• Device Catalogue Number: 4540008
• Device Lot Number: 21H14GE221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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