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
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.
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.
Additional Manufacturer Narrative
This complaint has been identified as b braun medical internal complaint number (b)(4).The actual device involved in the reported incident was returned for evaluation.When the device was evaluated the reported issue was not observed.The device operated as intended.Details of history log: log review shows on 3/10/2026 and 1:47pm an infusion was stopped, pump was placed on standby and powered-off at 1:59pm.At 2:17pm pump was powered-on and infusion set-up of bd 30ml syringe and 4.68ml/hr (dose rate.05mcg/kg/min; patient weight 78kg; dl:remifntl), then at 2:18pm syringe holder was opened.At 2:54pm a user hint displayed and bd 30 syringe was selected followed by syringe holder being opened.At 3:07pm bd 30 syringe was selected followed by syringe holder being opened.At 3:08pm bd 30 syringe was selected and at 3:14pm a user hint displayed and infusion start.At 3:23pm with volume infused to 0.74ml, new rate was selected of 6.55ml/hr (0.70 mcg/kg/min).At 3:26pm syringe near empty alarmed and at 3:29pm syringe empty alarmed stopping infusion with volume infused to 1.44ml, and at 3:30pm syringe holder was opened.At 3:31pm a bd 30 syringe selection and infusion start.At 3:42pm infusion was stopped with volume infused to 2.65ml.At 3:43pm new rate was set to 9.36ml/hr (0.1mcg/kg/min) and infusion start.At 3:55pm with volume infused to 4.56ml new rate was set to 4.68ml/hr (0.05mcg/kg/min) followed by infusion stop with volume infused to 4.59ml, with no bolus being administered, pump being placed on standby and no further infusions taking place that day.Preventative maintenance was performed.

• Brand Name: PERFUSOR®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; 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: 24716695
• Report Number: 9610825-2026-00156
• Device Sequence Number: 12194110
• 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
• PMA/510(K) Number: K172831
• 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,Followup
• Report Date (Section B): 04/15/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown