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

Catalog Number	8713052U
Medical Device Problem Code	False Alarm (1013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample, serial number, or device logs were provided.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: the pump was administering a fentanyl infusion at a rate of 250 mcg/hr but consistently triggered high down pressure alarms.The infusion line was disconnected, flushed, and reattached to the stopcock, ensuring it was in the open position.Despite increasing the pump pressure to 9, the high-pressure alarms continued to occur.The line was examined for air bubbles or blockages, successfully primed, yet the alarms persisted.A new line was attempted, but the problem remained unresolved.Ultimately, switching to a new pump rectified the issue.Throughout this process, the patient was also receiving norepinephrine at 0.1 mcg/kg/min, vasopressin at 2.4 units/hr, epinephrine at 0.04 mcg/kg/min, dopamine at 5 mcg/kg/min, propofol at 4 mg/kg/hr, a bolus, and a kcl sliding scale.

• Brand Name: INFUSOMAT®
• 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 MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21652847
• Report Number: 9610825-2025-00118
• Device Sequence Number: 15780134
• Product Code: FRN
• UDI-Device Identifier: 04046964708626
• UDI-Public: (01)04046964708626
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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: 8713052U
• 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: 02/24/2025
• Initial Report FDA Received Date: 03/20/2025
• 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