MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PERFUSOR®; PCA SYRINGE PUMP

Catalog Number	8713031U
Medical Device Problem Codes	Device Alarm System (1012); Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)
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 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.
Event or Problem Description
As reported by the user facility: according to the complainant, after assuming care of infant mrn, lipid infusion was programmed at the ordered rate and verified with another nurse (rn).At approximately 1740, the infusion pump indicated that the lipid infusion was complete.Upon assessment, it was noted that approximately 60 milliliters (ml) of lipids had infused despite the correct rate being programmed and verified.At that time, all infusion pumps in use were blinking blue and displaying a message indicating that the pump required an update.The provider, charge nurse, and transport nurse were promptly notified of the discrepancy.Per provider orders, the lipid infusion was discontinued.No patient complications were reported as a result of this event.

• Brand Name: PERFUSOR®
• Common Device Name: PCA SYRINGE PUMP
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer Contact: elena reifenstein ; 901 marcon blvd.; allentown, PA 18109 ; 8334251464
• MDR Report Key: 24521197
• Report Number: 9610825-2026-00117
• Device Sequence Number: 15875965
• Product Code: MEA
• UDI-Device Identifier: 04046964797958
• UDI-Public: (01)04046964797958(11)231114(10)97057672I3
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092313
• 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): 04/24/2026

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: 8713031U
• Device Lot Number: 97057672I3
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2023
• 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