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

Catalog Number	8713080U
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Section b: condition of returned samples sample status: [x] no sample returned sample returned.Active device history log review: n/a defect confirmed [x] defect not confirmed details of history log: log review shows on (b)(6) 2026 and 7:02pm a continuing infusion with volume infused to 9.86ml and infusion start of 25ml/hr and 12ml (bd 20 syringe).At 7:30pm infusion was stopped with volume infused to 21.46ml and new vtbi set to 1.4ml and at 7:30pm an infusion start.At 7:32pm an infusion stop with volume infused to 22.33ml.At 7:36pm new vtbi set to 19ml and infusion start and stop with volume infused to 22.38ml at 7:37pm new therapy selected and infusion start of 0.5ml/hr and 13ml and at 7:38pm infusion was stopped with no volume infused and syringe holder opened.No sample, serial number, were provided however, a review of unit history files determined that the issue was not confirme.Further investigation of the complaint is not possible without a sample and/or device logs.The reported defect was unable to be confirmed.The actual defective device is valuable tool in investigating the cause of this incident.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.
Event or Problem Description
As reported by the user facility: potential issue with the iv infusion pump/programming leading to likely medication error recognized as fentanyl syringe scanned and started at 1854, immediately prior to change of shift alarmed with vtbi warning and appears empty at approx.1945.Gtb app, charge nurse, and pharmacy notified without further interventions needed as patient is already intubated and mechanically ventilated.No signs of complications noted aside from decreased raas.Propofol dose cut significantly to assess neuro status.

• 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: elena reifenstein ; 901 marcon blvd.; allentown, PA 18109 ; 8334251464
• MDR Report Key: 25072227
• Report Number: 9610825-2026-00209
• Device Sequence Number: 16139238
• Product Code: MEA
• UDI-Device Identifier: 04046963915308
• UDI-Public: (01)04046963915308(11)230113(10)97041806K2
• 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
• Report Date (Section B): 05/04/2026

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: 8713080U
• Device Lot Number: 97041806K2
• 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: 04/16/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• 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