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

Model Number	8713030
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the event description: volume reflected should be 820 micrograms (mcg) in total, but shown as 796.4 micrograms (mcg) in total.Volume reflected should be in whole number and not in decimal point.
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.
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.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) 2024 and (b)(6) 2024 were investigated.A terumo 50ml syringe was selected and a pca therapy was started.During the therapy the pressure alarm occurred, two times.The reason for the pressure alarm could not be clarified.At the end of the infusion, a bolus was given 43 times.Overall, 41,82ml was infused.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: 20967992
• Report Number: 9610825-2024-00915
• Device Sequence Number: 12852367
• Product Code: FRN
• UDI-Device Identifier: 04046963716745
• UDI-Public: (01)04046963716745(11)230118(10)97044277A3
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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 Model Number: 8713030
• Device Lot Number: 97044277A3
• 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: 11/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2023
• 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
• Patient Sex: Unknown