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

Catalog Number	363904
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
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: unknown) was being used to administer milrinone at 9.6 milliliters (ml) per hour on (b)(6) 2024.According to the complainant, the pump repeatedly detected air in line despite both manual priming and priming through the pump.Additionally, the iv tubing was removed and reloaded to ensure proper loading.The complaint device has not been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number: (b)(4).Two (2) photos were submitted for evaluation.A visual examination was performed, which revealed a used set containing both liquid and air bubbles, indicating the presence of air within the line.Based on the photos provided, the reported defect of air in line was confirmed.However, without a physical sample and/or lot number, a thorough investigation could not be conducted.This report will be maintained for future reference and similar occurrences in other reports will continue to be monitored.Should any additional relevant information become available, a follow-up will be provided.

• 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: 20609074
• Report Number: 2523676-2024-00983
• Device Sequence Number: 15436046
• 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