MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG INFUSOMAT®; PUMP, INFUSION

Catalog Number	8713050
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow-up will be submitted when the investigation results become 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
According to the event description: "friday (b)(6) 2025 1411hr started therapy using pure hartmans solution vbti set at 500ml @ 1000ml/hr.Expected completion time 1441hr.At 1443 alarm kvo on pump.Nurse noted that there is a change in rate from 1000ml to 500ml.Found that bag was not empty and had some liquid left.".
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The uploaded history files were analyzed.The pump was turned on the (b)(6) 2025.The infusomat space was used for several different infusion therapies.On the (b)(6) 2025 a flow rate of 500ml/h and a time of 30 minutes were set by user.The therapy was started with 500ml/h at 02:12pm.At 02:42pm the flow rate was set to 1000ml/h by user.The vtbi near end alarm occurred at 02:52pm.The therapy was stopped at 02:54pm.The under infusion was caused by a wrong setting of the user.500ml/h were set instead of 1000ml/h.No pump was sent to melsungen for investigation.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.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: INFUSOMAT®
• Common Device Name: PUMP, INFUSION
• 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, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 22113391
• Report Number: 9610825-2025-00328
• Device Sequence Number: 4109696
• Product Code: FRN
• UDI-Device Identifier: 04046963716752
• UDI-Public: (01)04046963716752(10)97015902D1
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K083689
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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
• Device Catalogue Number: 8713050
• Device Lot Number: 97015902D1
• Was Device Available for Evaluation?: No
• 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: 05/30/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown