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

Catalog Number	8713032U
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).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: "pump was programmed as usual to run 2 mcg/kg bolus × 10 min, followed by 1 mcg/kg/h infusion.The child was sedated as expected.Before transferring into the mri, (b)(6) checked the pump and noticed it did not beep (it should beep after 10 min and automatically switch to the maintenance infusion).The bolus was still running after 10 min.She manually switched it to the infusion.The pump indicated the patient received 2.338 of 2 mcg/kg.".

• 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: 24743157
• Report Number: 9610825-2026-00161
• Device Sequence Number: 12947605
• Product Code: FRN
• UDI-Device Identifier: 04046964797965
• UDI-Public: (01)04046964797965(11)211126(10)97024448J1
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: 8713032U
• Device Lot Number: 97024448J1
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2021
• 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