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

Catalog Number	8713030
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 internal report number (b)(4).A follow-up report will be provided after the examination results are available.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.
Event or Problem Description
According to the customer: "on (b)(6) 2025, at about 2032hrs, rn noted that the fentanyl was running at 50mcg/hr (1ml/hr) instead of 15mcg/hr (0.3ml/hr).Fentanyl was topped up at 0015hrs." no patient complications were reported as a result of this event.
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.Additional information h4: device manufacturer date.The device was not available.Only the history data was sent for investigation.Results: the device history files were analyzed.The device history files from (b)(6) 2025 were analyzed.At 00:21am a rose rate of 50.000 microgram/hour with a rate of 1ml/h was selected and the infusion started.After 12 minutes the infusion stopped and a syringe change was performed.A terumo 20ml syringe was selected and the infusion was started again with the same rate and dose rate.At 12:34am a volume of 20ml was selected and at 8:33pm the volume was reached.At 8:54pm a syringe change was performed, again.A terumo 20my syringe was selected and the infusion started again with the same rate and dose rate at 8:54pm.One minute later, the infusion was stopped and he dose rate was change to 15.000 microgram/hour and a rate of 0.3ml/h.The infusion was started and at 9:32pm stopped.The pump was set into stand-by.No other abnormalities were found.Judgment: the complaint could not be confirmed.

• Brand Name: PERFUSOR®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21634867
• Report Number: 9610825-2025-00131
• Device Sequence Number: 20705343
• Product Code: FRN
• UDI-Device Identifier: 04046963716745
• UDI-Public: (01)04046963716745(10)96958407G5
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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: 8713030
• Device Lot Number: 96958407G5
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2014
• 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