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

Model Number	8713050
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
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: "we were informed a patient present to (b)(6) on (b)(6) 2024 (time unknown) into the acute treatment area.The patient was given iv crystalloid fluids (actual fluid/amount/rate all unknown) informed they were delivered into a peripheral cannula via the b.Braun infusomat space pump with the space airstop line (line or pump).Please note: we have no further information ref serial numbers/batch numbers.The child had signs of 2 x clinical seizures, with the likelihood of an air embolism in the brain post scans.Hyperbaric therapy was also given to the child, the child has since been discharged home we were advised." 12hours.
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Please note, this device is distributed outside the us and no gudid information exists.It is being reported due to a similar device being marketed within the us with the following info: udi number (b)(4).Premarket submission # (b)(4).Additional information d4: device information updated, d9 device returned to manufacturer, h4: device manufacturer date.General information: complaint: (b)(4).Information to the sample: model: infusomat space.Article number: 8713050.Serial number/batch: (b)(6).Software version: n030005.Hours of operation: 813.Further information: n/a.Investigation results: history inspection: the device history files were read and analyzed.The device history files from 2024-12-04 were investigated.The air bubble alarm could be found in the history files, two times.No other abnormalities were found in the device and alarm history.Visual inspection: a visual inspection was performed.The cover caps on the screw pillars, and the technician seal (61-02-020) on the lower housing were intact and undamaged.The device is in a clean state and no visible damaged are to locate.Functional inspection: a functional test was performed.The device passes the self test.A space line was inserted, and the pump identified the line and it could be selected from the menu.It was possible to put the pump in operation.Individual inspection: for checking the air-sensor a space line was filled with water and was inserted in the infusomat.With the operating unit closed, a value of 43mv (rated value < 100mv) was measured for the air and a value of 1931mv (rated value between 1100mv[?]2250mv) was measured as water equivalent.All measured values are within our specification.Furthermore, the pump was started with a rate of 250ml.With the help of an omnifix-h 1ml syringe scattered bubbles of 0,1ml and 0,25ml were injected to test the correct function of the air sensor.All measured values are within our specification.A long-term test about 24 hours was performed.A space line was inserted, and the infusion started with a rate of 250ml/h.During the infusion no malfunction could be detected.Disassembling: during the investigation no faults could be detected, to investigate the inside of the device, only the upper housing was removed.No damage or soiling could be found.Judgment: the complaint could not be confirmed.Summing up all tests, the infusomat space operates within our specification.No product deviation.

• 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: 21412849
• Report Number: 9610825-2025-00093
• Device Sequence Number: 13125540
• Product Code: FRN
• UDI-Device Identifier: 04046963716752
• UDI-Public: (01)04046963716752
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown