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

Model Number	4540010-02
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun (b)(4) internal report (b)(4), event 1: 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)(6): event 1 "overinfusion" "the client encountered a problem in 2 of their patients for whom they installed 24-hour diffusers for the administration of analgesics.Indeed, the product was delivered too quickly, for a duration according to the statements of the patients of 8h, 9h and 12h instead of the expected 24 hours.The patient did not received him treatment during the expected duration so he was not relieved of his pain as he should the medication has been administrated per os when the defect has been detected.".
Additional Manufacturer Narrative
This report has been identified as b.Braun melsungen ag internal report # (b)(4).We received one used, empty easypump ii lt 60-30-s.Weight of the sample in received condition: 67.7 g.The following investigations were conducted: visual inspection: the received sample was taken to a visual inspection.After opening of the big top cap and removing of the closing cone we detected solution at the filling port (lli-cone) and at the patient connector of the sample.The white clamp is closed, and the patient connector (lla-cone) was closed with a combi stopper (the original wing cap was not submitted from the customer) at the sample.Damages that would lead to a malfunction was not detected at the received sample.Functional inspection: in addition, the sample was taken to a functional test respectively a leak test was carried out.Therefore, the pump was filled up to the nominal volume (60 ml) with nacl 0.9 %.After starting the pump, the pump worked immediately (solution was running).Leakages were not detected at the received sample.Physical inspection: furthermore, the flow rate of the pump was tested.Nominal: 2 ml/h.Actual 2.4 ml in 1 h; 4.6 ml in 2 hrs; 33.8 ml in 18 hrs.A too fast flow of the pump (as described by the customer) could not be detected.The flow rate of the pump is within our specifications.Therefore, we consider the complaint as not confirmed.Device history record (dhr): reviewed the dhr for batch 21d07ge231, there is no abnormality and no such defect detected at in process and at final control inspection.

• 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: 12728101
• Report Number: 9610825-2021-00452
• Device Sequence Number: 19202427
• Product Code: MEB
• UDI-Device Identifier: 04046964448515
• UDI-Public: (01)04046964448515(17)260401(10)21D07GE231
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2021

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 Expiration Date: 04/01/2026
• Device Model Number: 4540010-02
• Device Catalogue Number: 4540010
• Device Lot Number: 21D07GE231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown