MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INFOSMAT®; SET, ADMINISTRATION, INTRA

Catalog Number	490101
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.Please note: customer provided an incomplete lot number "006183664" which cannot be verified.It will be updated if the actual lot number becomes available.
Event or Problem Description
As reported by user facility: brief inquiry description air in line from y-connector at proximal port to patient detailed inquiry description air in line from y-connector at proximal port to patient description of the patient event pump infusing, nurse noticed air in line and bubbling at y-connector no injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Although the defect could not be confirmed, corrective actions were performed to revise specifications which limit unit-to-unit variation in tubing outer diameters and increased the length of the tubing that contacts the air sensor.The reduced variation in tubing outer diameter and length revision improves the coupling between the administration set and the air-in-line sensor reducing the potential for false air-in-line alarms.B.Braun medical inc.Has initiated a voluntary medical device correction 2523676-9/26/23-004-c for multiple batches of infusomat® pump sets manufactured between 01.Jan.2022 and 17.Aug.2023.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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One used sample was provided for evaluation.Upon visual inspection of the returned sample, no defects were observed.To replicate the reported defect, the sample was attached to the pump and then tested by running therapy while staggering the flow rate throughout the therapy.No alarms occurred during the testing.The sample was leak tested and no leakages were observed.A measurement of the outer diameter of the pump segment tubing was taken and found to be within specification.Based on the data from the investigation, the reported defect was unable to be confirmed.Corrective actions were performed to revise specifications which limit unit-to-unit variation in tubing outer diameters and increased the length of the tubing that contacts the air sensor.The reduced variation in tubing outer diameter and length revision improves the coupling between the administration set and the air-in-line sensor reducing the potential for false air-in-line alarms.B.Braun medical inc.Has initiated a voluntary medical device correction 2523676-9/26/23-004-c for multiple batches of infusomat® pump sets manufactured between 01.Jan.2022 and 17.Aug.2023.Five retains from the reported lot number were tested per specification and passed.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.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: INFOSMAT®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 19355625
• Report Number: 2523676-2024-00503
• Device Sequence Number: 7528829
• Product Code: FPA
• UDI-Device Identifier: 04046964186103
• UDI-Public: (01)04046964186103
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2025

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: 490101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 11/11/2024; 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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