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

Catalog Number	8713080U
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
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: when pump discontinued there was 4 ml/4 mg morphine left in syringe and pump showed 22.8 ml/mg.
Additional Manufacturer Narrative
This complaint has been identified as b braun medical internal complaint number (b)(4).The actual device involved in the reported incident was not returned for evaluation.The logs were provided for review.Logs show these pca infusions taking place: on (b)(6) 2025 and 12:40am a pca start of 30ml syringe; dl: morphine.At 8:40am infusion was stopped with a volume infused to 19.0ml.At 8:45am therapy was reset to zero volume and at 12:52pm syringe empty alarmed stopping the infusion with a volume infused to 10.57ml.At 1:09pm 30ml syringe was selected and pca infusion continued.On (b)(6) 2025 and 7:00am syringe empty alarmed stopping infusion with a volume infused to 41.08ml at 7:10am 30ml syringe was selected and pca infusion continued.At 9:05pm with a volume infused to 67.08ml infusion was stopped with no further infusions taking place.All information concerning this reported incident has been included in our trend analysis of the product line.

• 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: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 22206093
• Report Number: 9610825-2025-00361
• Device Sequence Number: 7667491
• Product Code: MEA
• UDI-Device Identifier: 04046963915308
• UDI-Public: (01)04046963915308(11)241016(10)24272A5000
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 08/08/2025

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: 8713080U
• Device Lot Number: 24272A5000
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2024
• 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