MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INFUSOMAT®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	362035
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.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: details of complaint (reported issue): "air in line - not visible and unresolved.".Impact to patient: delay in treatment, interruptions to clinical care due to time required to resolve alarms.Action(s) taken changed out pump (isolate and send to bioengineering department), followed b.Braun tips to resolve alarms (air-in-line and occlusion), repeated priming to clear air, tubing replaced (triple bag and send to material management), other.Medication / fluid kp04 30mmol.Iv rate 93ml/hour.Other details this is a high alert medication, in which the patient requires all of the medication that is in the supplied bag.All of the b braun trouble shooting interventions were utilized.Not only is it delay in medication administration, took an additional 2-3 hours of additional time, it is also a heavy amount of time in which nursing had to spend problem solving, while providing care to an additional 6 patients and assisting with all the care needs of the unit.As the nurse administering the medication, we were in the room minimally 6-10 times an hour responding to pump alarms.Thus, delaying the care of other patients.This was also very disruptive to the patients sleep.

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 23426953
• Report Number: 2521402-2025-01323
• Device Sequence Number: 12832333
• Product Code: FPA
• UDI-Device Identifier: 04046964699047
• UDI-Public: (01)04046964699047
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2025

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: 362035
• 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: 10/15/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown