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

Model Number	363902
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: event 1: detailed inquiry description: the clinician was struggling with air in line during vancomycin infusion no injury reported.
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.
Additional Manufacturer Narrative
Event 1: this report has been identified as b.Braun medical internal report number (b)(4).One used sample with open packaging and four photographs were provided for evaluation.The sample and photographs were visually evaluated, and no defects were observed on the physical sample.In the photographs provided, microbubbles were visible in the tubing and the iv bag.In an attempt to replicate the reported defect of the air-in-line alarm on the pump, the physical sample was attached to the pump and then tested by running therapy while staggering the rate of flow throughout the therapy.No alarms occurred during the testing of the returned sample.The sample was also leak-tested with passing results.Based on the photos provided, the reported defect was confirmed.Although the photographs were confirmed and the air in line could not be replicated, a possible root cause of air in line alarms could be related to an incomplete priming of the iv line, infusion of cold solutions which may exhibit air bubbles coming out of solution as the fluid warms, or incomplete filling of the drip chamber during priming.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.In addition, review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.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: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICIAN REPULIC 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: 17343372
• Report Number: 2523676-2023-00353
• Device Sequence Number: 6524073
• Product Code: FPA
• UDI-Device Identifier: 04046964294730
• UDI-Public: (01)04046964294730
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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: 363902
• Device Catalogue Number: 363902
• Device Lot Number: 0061866016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• 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