MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG PERFUSOR®; SPACEPLUS PERFUSOR

Model Number	8719030
Medical Device Problem Code	False Alarm (1013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One sample and the device logs were provided for evaluation.Upon visual evaluation of the sample, the cover caps on the screw pillars and the seal on the lower housing were intact and undamaged.The device was in a clean state.It was found that the claws were not fully inserted in the claw mechanism and the rubber seal of the drive head was damaged.Upon review of the provided device logs, the described error pattern could be comprehended in the history analysis.Based on the data from the investigation, the reported defect was confirmed.The root cause of the reported issue was a result of a software anomaly.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in theunited states by b.Braun medical, inc.
Event or Problem Description
According to the event description: "as per night shift staff, they noted the pump beeping two times with the error of 'empty syringe' showed on the pump.When the first error beeping, they checked and noted the syringe was in place and continue the infusion.When second time they encountered same issue, they changed another syringe pump with the existing meds running.".

• Brand Name: PERFUSOR®
• Common Device Name: SPACEPLUS PERFUSOR
• 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 blvs.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 22088696
• Report Number: 9610825-2025-00280
• Device Sequence Number: 15468997
• Product Code: FRN
• UDI-Device Identifier: 04046963716752
• UDI-Public: (01)04046963716752
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2025

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
• Device Model Number: 8719030
• Device Lot Number: 23202A5002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown