MAUDE Adverse Event Report: B. Braun Melsungen AG Perfusor®; Pump, Infusion

Catalog Number	8713031U
Medical Device Problem Codes	Device Alarm System (1012); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: Perfusor®
• 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 ; 824 12th ave; bethlehem, PA 18180 ; +1(833)435-1464
• MDR Report Key: 50122216
• Report Number: 9610825-2026-00393
• Device Sequence Number: 21452280
• Product Code: FRN
• UDI-Device Identifier: 04046964797958
• UDI-Public: (01)04046964797958(11)250804(10)25205A5001
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/06/2026

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: 8713031U
• Device Lot Number: 25205A5001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2025
• 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: Other
• Patient Sex: Unknown