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

Catalog Number	8713031U
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the user facility: anesthesiologist began anesthesia induction and shortly after noted that the patient started seizing.Patient was emergently intubated to protect the airway, was stabilized and surgery was able to be completed.Post-operatively patient remained intubated and remained in icu overnight.The patient was extubated in the morning and reports are that there are no signs of impairment.Based on a review of the keyboard history and device history reports biomed obtained from the pump, the pump was programmed starting at 2:17 pm and at 2:18 pm the syringe holder was opened.There is no data until 2:54 pm at which time there was an error followed by syringe brand and size was selected with a syringe fault error.

• Brand Name: PERFUSOR®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• MDR Report Key: 25148298
• Report Number: 2521402-2026-00506
• Device Sequence Number: 10750131
• Product Code: FRN
• UDI-Device Identifier: 04046964797958
• UDI-Public: (01)04046964797958(11)201205(10)97009126J0
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/12/2026
• Report Date (Section F): 05/12/2026

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: 8713031U
• Device Lot Number: 97009126J0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/16/2026
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2026
• 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; Hospitalization
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/12/2026