MAUDE Adverse Event Report: B. BRAUN MELSUNGEN 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)
Date of Event	05/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: pump was setup for a primary and secondary infusions.At approximately 1900, this rn noticed that there may have been a malfunction with braun pump.The iv pump was programmed to deliver piperacillin-tazobactam (zosyn) 3.375 gram in sodium chloride 0.9% (ns) 50 ml ivpb at 12.5 ml/hr and started at 17:53.At shift change approximately one hour later, this rn found the iv bag empty, which was inconsistent with the expected remaining volume.This suggested the pump may have infused the medication at a rate different from what was originally programmed and verified.The infusion was stopped, the charge rn was notified, and the pump and medication bag were removed from patient's room.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

• 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: elena reifenstein ; 901 marcon blvd.; allentown, PA 18109 ; 8334251464
• MDR Report Key: 25360922
• Report Number: 9610825-2026-00258
• Device Sequence Number: 16134793
• Product Code: FRN
• UDI-Device Identifier: 04046964660887
• UDI-Public: (01)04046964660887(11)201202(10)97008433J0
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: 8713051U
• Device Lot Number: 97008433J0
• 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: 05/11/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2020
• 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