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

Catalog Number	8713032U
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility:during an on-site integration workflow event with oracle health, the nicu nurse educator at epch reported occasions in which perfusor syringe pumps infused volumes that were significantly less than expected.For example, if the nurse anticipated that 45 ml should have infused by a certain time, the pump only infused 38 ml.Nurse educator unable to define specific pump, patient, medication, or date/time details, citing multiple recent instances of these challenges.She reported that nurses have pulled impacted pumps from circulation for biomed inspection, but the issue has occurred repeatedly.The educator indicated that this issue is often detected with narcotics due to the close monitoring associated with the infusions.She denied the occurrence of occlusion alarms in these cases.Advised to send impacted devices to biomed for further investigation upon next event (if applicable) and to report specific details for additional assessment.
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 report has been identified as b.Braun medical internal report number (b)(4).The device and device logs were not made available for evaluation.

• Brand Name: PERFUSOR®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; 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: 23075950
• Report Number: 9610825-2025-00532
• Device Sequence Number: 18576368
• Product Code: FRN
• UDI-Device Identifier: 04046964797965
• UDI-Public: (01)04046964797965
• 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: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

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: 8713032U
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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