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

Catalog Number	8713052U
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample, serial number, were provided however logs were provided and a review of them was performed.Results of the logs review says: [x] defect not confirmed.Details of history log: log review shows on (b)(6) 2025 and 4:35am an infusion start of 7.5ml/hr and 100ml (dl: fentdrip).At 4:38am with volume infused to.43ml rate was set to 10ml/hr.At 4:42am with volume infused to 1.05ml infusion was stopped.At 5:00am infusion was started and at 6:00am upstream pressure alarm stopped the infusion with volume infused to 11.01ml.At 6:04am infusion was started and at 7:35am infusion was stopped with volume infused to 26.25ml and pump was placed on standby.At 7:43am pump was brought out of standby and infusion started and at 10:23am infusion was stopped with volume infused to 52.89ml and at 10:26am door was opened.At 10:29am infusion continued with multiple rate changes until kvo occurred with a volume infused to 100ml.Further investigation of the complaint is not possible without a sample.The reported defect was not confirmed.The actual defective device is valuable tool in investigating the cause of this incident.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.
Event or Problem Description
As reported by the user facility: pt went from ed to or and was intubated and started on fentanyl.There was a series of dosing changes and starts and stops and the 100 ml bag was empty before it should have been completed based on the programming.

• Brand Name: INFUSOMAT®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 22903096
• Report Number: 9610825-2025-00516
• Device Sequence Number: 12974594
• Product Code: FRN
• UDI-Device Identifier: 04046964708626
• UDI-Public: (01)04046964708626(11)171116(10)96967274D7
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K142596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

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 Catalogue Number: 8713052U
• Device Lot Number: 96967274D7
• 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: 08/12/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2017
• 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