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

Catalog Number	8713031U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); Compartment syndrome (4888)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the user facility: potential contribution of pump to the iv infiltration and subsequent compartment syndrome that resulted in patient needing a fasciotomy.More information to come pending customer sending answers to additional questions.Major concern is not receiving a downstream occlusion alarm but customer recognized pump is measuring pressure in line down through iv not in surrounding area.

• 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: 23367192
• Report Number: 2532083-2025-00003
• Device Sequence Number: 8894220
• Product Code: FRN
• UDI-Device Identifier: 04046964797958
• UDI-Public: (01)04046964797958(11)231228(10)97060128K3
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/23/2025
• Report Date (Section F): 10/23/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8713031U
• Device Lot Number: 97060128K3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/07/2025
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2025
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/23/2025