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

Catalog Number	363904
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two (2) photo were provided for evaluation.A visual examination was performed, and it was noted that air bubbles were inside the tubing of the sample.Based on the photos the reported defect of air in line was confirmed.Although the defect was confirmed, due to no sample and/or lot number a thorough investigation was unable to be performed.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.
Event or Problem Description
As reported, air in line.Frequently beeps for bubbles.No bubbles detected when line examined.

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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; km 22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109
• MDR Report Key: 20609740
• Report Number: 2523676-2024-00985
• Device Sequence Number: 7411279
• Product Code: FPA
• UDI-Device Identifier: 04046964177354
• UDI-Public: (01)04046964177354
• 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): N
• 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): 11/05/2024

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: 363904
• 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: 10/07/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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