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).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 customer: "equipment malfunctioned where it marked that it had infused 130 ml and had infused about 20 ml." no patient complications were reported as a result of this event.
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.Investigation: the historical data of the device in question was extracted, and the operation history of the equipment was evaluated.The user did not provide the date of the adverse event or the programming in use.Therefore, we searched the usage history for the recorded infused volume closest to what the user reported to conduct an analysis of the usage history.We identified that on (b)(6) 2025, the user selected the drug "dexmed" from the drug library, programming a flow rate of 28.2 ml/h and a volume of 100 ml, starting the infusion at 08:29 and stopping it at 12:11.We verified that the user modified the flow rate to 47 ml/h, and the infused volume was 97.02 ml.At 12:12, the user made another modification to the programming, restarting the infusion and changing the volume to 61.28 ml, without resetting the already infused amount.At 12:54, the infusion was stopped, and the total infused volume recorded was 131.41 ml.We confirmed that the infused volumes and infusion times were consistent with the programming and the user's actions, as attached.Through a visual inspection of the equipment, natural signs of use were observed.The equipment underwent functional performance tests using the last two programming entries made by the user.The results of the functional tests demonstrated that the equipment is working correctly and precisely within its specifications, therefore not confirming the complaint.All information has been recorded in a global customer complaint database and will be used for trend analysis.

• 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: 21363239
• Report Number: 9610825-2025-00026
• Device Sequence Number: 8518989
• Product Code: FRN
• UDI-Device Identifier: 04046963716752
• UDI-Public: (01)04046963716752
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/10/2025

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/10/2025
• 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