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	Malfunction
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.
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.
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 not returned for evaluation but the logs were provided for review.Log review shows on (b)(6) 2025 a continuing infusion of 144.75ml and drug library dexmed4 and at 2:29am a bd 50ml syringe selection and infusion start of 4.35ml/hr (1.5mcg/kg/hr) and 50ml.At 7:22am with a volume infused to 166.03ml infusion was stopped.At 10:26am an infusion start and at 11:28am with a volume infused to 170.53ml infusion was stopped.At 11:33am an infusion start and at 2:38pm with a volume infused to 183.9ml new dose rate was set to 1mcg/kg/hr (2.9ml/hr) and at 2:47pm with volume infused to 184.34ml infusion was stopped.At 2:59pm an infusion start and at 4:05pm with a volume infused to 187.54ml infusion was stopped with no further infusions taking place and no pressure alarms occurring during these infusions.The defect was not confirmed.All information concerning this reported incident has been included in our trend analysis of the product 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: 23367228
• Report Number: 9610825-2025-00610
• Device Sequence Number: 8916196
• 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
• 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): 11/12/2025

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?: Yes
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2023
• 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