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

Model Number	4540032-02
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun melsungen ag 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" "on 2 pumps of the batch 21f23ge341 the pump ran through much too fast.For both patients, the pump was attached on friday morning and for one patient it had already run through on sunday at 8:00 a.M.And for the other it had already run through on saturday evening.We got both pumps back from the station and could send them to you.".
Additional Manufacturer Narrative
This report has been identified as b.Braun melsungen ag internal report # (b)(4): we received two used and empty easypump ii lt 270-135-s without packaging.The following investigations were conducted: visual inspection: the received samples were taken to a visual inspection according to the test method for damages.Definition of the method: damages are visible changes in the original shape or surface of products and packaging caused by mechanical forces and/or manufacturing faults.Nominal: no damage is allowed that endangers the patient, impedes the use of the part as intended (e.G., the impairment of the function of a drop sensor), endangers the assembly or function of the component, impairs the appearance of the component.Actual: we detected no damages or manufacturing faults.As-received condition: sample 1: the white clamp is open, and the patient connector were closed (combi-stopper), the original wing cap was not handed over by the customer.Sample 2: the white clamp is closed, and the patient connector were closed (combi-stopper), the original wing cap was not handed over by the customer.Weight of the empty samples: sample 1: 77.6 g sample 2: 75.1 g functional inspection: in addition, the received sample was filled up with 270 ml nacl 0.9% and was taken to a functional test respectively a leak test was carried out.After opening the patient connector and the white clamp, the pump works properly (solution was running) at the sample.Leakages were not detected.Physical inspection: the flow rate of the pump was tested.Nominal: 2 ml/h actual: sample 1: 3.4 ml in 1 h; 6.6 ml in 2 hrs; 144.4 ml in 70 hrs.Sample 2: 2.9 ml in 1 h; 5.1 ml in 2 hrs; 108.9 ml in 70 hrs.The flow rate of sample 1 is within the specification.The flow rate of sample 2 is not within the specification.A too fast flow (as described by the customer) could not be determined at the received samples.Summary and assessment: a too fast flow (as described by the customer) was not detected at the sample.A too fast flow (as described by the customer) could not be determined at the received samples.The flow rate of sample 2 is to slow.Therefore, the complaint is considered 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
• 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: 13952277
• Report Number: 9610825-2022-00108
• Device Sequence Number: 6432036
• Product Code: MEB
• UDI-Device Identifier: 04046964448843
• UDI-Public: (01)04046964448843(17)260601(10)21F23GE341
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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 Model Number: 4540032-02
• Device Catalogue Number: 4540032
• Device Lot Number: 21F23GE341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 08/18/2022
• 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