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

Model Number	8713050
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are available.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.
Event or Problem Description
According to the customer: "report from the unit's nurses: chemotherapy was running pump finished the medication before it was defective.Patient:(b)(6).N/a: (b)(6) bed : 1516 medication: etoposide / vincristine / doxorubin period: (b)(6) to (b)(6).Initial programming: medication should run in exactly 24 hours.Case description: medication began , however, it will close.Was there a clinical worsement: no the patient's condition worsened.".
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.Additional information d9 device returned to manufacturer sample information: infusomat space, 8713050 serial no.: (b)(6).History files inspection: as reported by the user on (b)(6) 2025, the volume of 265ml and the flow rate of 11.05ml/h were programmed to occur in 24 hours.The infusion was started at 20:18:49 on (b)(6) 2025.The already infused upstream volume of 691.05ml was not reset.The infusion was stopped at 09:48:05 on (b)(6) 2025 because the equipment detected air in the infusion line.The user confirmed the alarm and removed the air from the line.The upstream volume was 840.08ml.The infusion was restarted at 09:59:54 on (b)(6) 2025.The infusion was stopped at 16:30:05 by the equipment due to pressure in the infusion line.The amount of volume infused was 911.55 ml.The infusion was restarted at 16:35:55 and stopped at 16:54:30 due to an air alarm in the line.The user confirmed the alarm and removed the air from the line.The amount of volume was 914.98 ml.The user changed the volume to 30 ml at 17:31:14 on (b)(6) 2025.However, the amount of volume already infused was not reset.The infusion was restarted at 17:32:55 and stopped at 18:11:43 for the last time.The amount of volume infused was 922.12 ml.The total volume infused was: [(922.12ml (final volume)) # (691.05ml (initial volume not reset)) = (231.07ml)].Total infusion time, considering programming, user actions and equipment alarms: 21h52min54 functional inspection: technical complaint: error in the infusion time.On (b)(6) 2025, the volume of 265ml and the flow rate of 11.05ml/h were programmed to occur in 24 hours.However, the infusion occurred in 21 hours.Percentage error of 12.5% in the infusion time.Functional test: we will use the same programming reported by the user.The user did not use the drug library.The equipment should perform the infusion according to the programming.Programmed flow rate: 11.05ml/h.Programmed volume: 265ml resulting time: 24h00min.Infused volume: 270ml ###error: +1.9%.Infusion time: 23h59min07 ##error: -0.1%.Result: approved.Visual analysis: equipment has a normal used appearance.Conclusion: the functional test result showed that the equipment is working correctly and precisely.Technical complaint of 12.5% error in infusion time not confirmed.In analyzing the usage history, the department found no evidence of errors in the infusion time or volume.The equipment worked correctly and precisely according to the user's programming and actions.The history does not confirm the technical complaint.The defect could not be confirmed.

• Brand Name: INFUSOMAT®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21549801
• Report Number: 9610825-2025-00128
• Device Sequence Number: 11923080
• Product Code: FRN
• UDI-Device Identifier: 04046963716752
• UDI-Public: (01)04046963716752
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 05/09/2025

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 Model Number: 8713050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 05/09/2025
• 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