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

Model 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	02/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are 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: on (b)(6) 2025, at 0924 hours staff put up the 500 milliliters (ml) compound sodium lactate, running at a rate of 41.67 milliliters an hour (ml/h) for over 12 hours, with intended volume to be infused (vtbi) of 500 milliliters (ml).At around 2320 hours the same day the pump alarmed and showed keep vein open (kvo) 0 milliliters (ml) near end.Nurse saw that the bag is full instead of empty.Nurse used the same bag and rekeyed in rate of 41.67ml/h for over 12 hours, with intended vtbi of 500ml.On (b)(6) 2025, at 1400 hours the pump alarmed and showedvfinish kvo.The bag was noticed to have an estimated remaining 400 milliliters (ml) left when it should be empty.Staff did not touch vent or orange roller.Line was not changed throughout incident.Airvent of tubing was observed to be kept closed.
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number: (b)(4).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 information: h4 device manufacturer date.No sample / underinfusion: the device was not available.Only the history data was sent for investigation.Results: the device history files were analyzed.The device history files from on (b)(6) 2025 were investigated.On (b)(6) 2025, a new volume of 500ml and a rate of 41,67ml/h was selected at 11:24 pm.On the next morning at 7:45am the infusion was stopped, and the pump was set into stand-by.At 10:06am the stand-by mode was over and the infusion started again.At 1:40pm the pre alarm "vtbi near end" occurred.5 minutes later the volume was reached and the kvo-mode (keep vein open) started.At this time, 500ml was infused.The infusion was stopped and the line was extracted.No other abnormalities were found.Judgment: the complaint could not be confirmed.

• 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: 21451478
• Report Number: 9610825-2025-00080
• Device Sequence Number: 7158368
• Product Code: FRN
• UDI-Device Identifier: 04046963716752
• UDI-Public: (01)04046963716752(10)97015902D1
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 04/08/2025

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
• Operator of Device: Health Professional
• Device Model 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: 02/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown