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

Catalog Number	8713050U
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	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Test result(s): defect confirmed [x] defect not confirmed.Results description: the reported issue was not present during investigation.Incoming pump inoperable due to device alarm 2013 internal error at power-on.Replace motherboard #34521348 and perform delivery accuracy check.The product evaluation determined that the reported issue was not confirmed.Incoming pump inoperable due to device alarm 2013 internal error at power-on.Active device history log review: n/a defect confirmed [x] defect not confirmed details of history log: log review shows last infusion on (b)(6) 2026 and 9:10pm with infusion start of 800ml/hr and 400ml (dl: mann20) followed by infusion stop at 9:10pm with volume infused to 0.15ml and pump put on standby.At 9:12pm pump was brought out of standby and infusion start.At 9:13pm pressure alarm stopped infusion with volume infused to 11.69ml.At 9:16pm an infusion start.At 9:45pm pump entered kvo with volume infused to 400ml and at 10:04pm infusion was stopped with volume infused to 409.21ml.At 10:04pm an infusion start with new vtbi set to 70ml.At 10:09pm pump entered kvo with volume infused to 479.21 and at 10:11pm infusion was stopped with volume infused to 480.09ml.No further infusions took place.On (b)(6) 2026 and 3:36pm pump was powered-on and new therapy selected but no infusion took place and pump was powered-off at 3:37pm.
Event or Problem Description
As reported by the user facility: over infusion.

• 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 AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• Manufacturer Contact: elena reifenstein ; 901 marcon blvd.; allentown, PA 18109 ; 8334251464
• MDR Report Key: 24717688
• Report Number: 9610825-2026-00155
• Device Sequence Number: 6087939
• Product Code: FRN
• UDI-Device Identifier: 04046963716752
• UDI-Public: (01)04046963716752(11)110330(10)5055833031
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/27/2026

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: 8713050U
• Device Lot Number: 5055833031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2011
• 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