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

Catalog Number	8713031U
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
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: technical evaluation of the device did not identify any nonconformances or device performance problems which would directly contribute to the reported event.Volumetrics of 100ml/hr and 10ml and 50ml syringe tested in spec at 9.97ml or 99% of expected accuracy.Volumetrics of 0.39ml/hr and 0.39ml tested in spec 0.39ml.
Event or Problem Description
As reported by the user facility: "nipride gtt ordered to be increased.This rn attempting to scan syringe for epic mar documentation, barcode was unable to be scanned and this rn needed to rotate syringe to scan.Line clamped, and syringe scanned.Pump reprogrammed and syringe replaced.When lever reached end of syringe, gave small "tap" to end of syringe, resulting in small bolus of nipride reaching patient.Patient blood pressure dropped to 40/20s per arterial line.".

• 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: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 23367803
• Report Number: 9610825-2025-00612
• Device Sequence Number: 10089619
• Product Code: FRN
• UDI-Device Identifier: 04046964797958
• UDI-Public: (01)04046964797958(11)240110(10)97060587K3
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 10/23/2025

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: 8713031U
• Device Lot Number: 97060587K3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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