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

Catalog Number	8713052U
Medical Device Problem Codes	Device Alarm System (1012); False Alarm (1013)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: the pump consistently triggered alarms for downstream occlusion, upward occlusion, and air in the line, occurring over 14 times within a three-hour period.This frequent alarming resulted in delays in insulin infusion, which subsequently caused fluctuations in the patient's blood sugar levels.Despite changing the line and the bag, as well as checking the sensors, no apparent issues were identified.Nevertheless, the alarms persisted throughout the shift.
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.

• 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 AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21720644
• Report Number: 9610825-2025-00174
• Device Sequence Number: 3993633
• 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): 03/28/2025

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: 03/05/2025
• Initial Report FDA Received Date: 03/28/2025
• 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