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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to b.Braun medical inc.That an infusomat space pump intravenous (iv) pump set (material 363904, lot 0061939231) was being used to administer milrinone on (b)(6) 2024.According to the complainant, the pump alarmed for air in line, however, there were no visible bubbles in the iv line.The complaint device has not been returned to the manufacturer for evaluation.From checklist: air in line.Used prime function to remove the air in the line and infusion restarted.Alarm reoccurs, used prime function again to remove the air in the line and restart infusion.Open door, remove and visualize tubing, tap the tubing section and observe for bubbles.No visible bubbles, reload the tubing and restart infusion.Alarm re-occurs.
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
This report has been identified as b.Braun medical internal report number (b)(4).No sample and one photograph was provided for evaluation.Upon visual inspection of the returned photograph, it was noted that the set was used, and air bubbles were present in the line.Based on the data from the investigation, the reported defect was confirmed.The exact root cause for the reported defect was unable to be determined at this time.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, 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: 20734490
• Report Number: 2523676-2024-01042
• Device Sequence Number: 8304862
• Product Code: FPA
• UDI-Device Identifier: 04046964699061
• UDI-Public: (01)04046964699061
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: 10/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 12/03/2024
• 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