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)
Type of Reportable Event	Malfunction
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.History / no sample no pump was sent for investigation.Only the history and pictures of the pump were available.According to the history files the pump was turned on at 02:10pm on the 16th of february 2025 (date of incident).After the line was selected (space line neutrapur) the vtbi therapy date were set by user.No technical malfunction was found in the log files during therapy from (b)(6) 2025.As per the defect description, no abnormalities were reported during the therapy time until 02:26.However, by 02:30, the pump indicated kvo = 0ml, while approximately 200ml remained in the bottle.This suggests a mismatch between the pump machine and the completed set, without any alarm from the pump machine, which could potentially affect the therapy process.Based on the customer's complaint, the product was used for six hours before an alarm occurred, with 200ml still remaining in the burette.This indicates no deviation with the product itself.The issue may be attributed to the machine, its setup, or the medicine, and is not related to the product.The complaint is not confirmed to be related to the product's assembly and packaging production.No damages, no functional faults and no leaks were detected at the received used sample.The complaint is considered as not confirmed.
Event or Problem Description
According to the event description: on (b)(6) 2025 at 202 6hours staff started running pump at a rate of 83.33 milliliters an hour (ml/h), intended volume to be infused (vtbi) 500 milliliters (ml) for 6 hours.Reportedly the infusion was supposed to end at 0226 hours.On (b)(6) 2025 at 0230 hours the pump showed keep vein open (kvo) = 0 milliliters (ml) but bottle has about 200 milliliters (ml) remaining.No patient complications were reported as a result of this event.

• 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: 21632162
• Report Number: 9610825-2025-00130
• Device Sequence Number: 12646474
• 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
• Report Date (Section B): 03/18/2025

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: 02/19/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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