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

Catalog Number	8713051U
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported in medsun report (b)(4), a nurse hung 20 meq kcl (50ml bag) to infuse over 60 minutes.When rn (registered nurse) returned, the entire bag had infused within about 5 minutes.Calcium gluconate 2 gm iv administered to prevent life threatening arrhythmia or death.Patient did not experience complications.As part of an internal nonconformance, this importer mdr is being submitted retroactively.Please note that the associated manufacturer mdr for this event, 9610825-2025-00020, had already been previously submitted timely on 03feb2025.As b.Braun medical, inc.Submitted the manufacturer mdr on behalf of the manufacturer, the importer mdr was inadvertently missed.

• Brand Name: INFUSOMAT®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• MDR Report Key: 25536088
• Report Number: 2521402-2026-00654
• Device Sequence Number: 9313198
• Product Code: FRN
• UDI-Device Identifier: 04046964660887
• UDI-Public: (01)04046964660887(11)240110(10)23251A5000
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2026
• Report Date (Section F): 02/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8713051U
• Device Lot Number: 23251A5000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/03/2025
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Date Report Sent to FDA: 02/03/2025