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

Catalog Number	363420
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
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.
Event or Problem Description
It was reported to b.Braun medical inc.That an infusomat space intravenous (iv) pump set (material 363420, lot 0061868575) was being used to administer paclitaxel on (b)(6) 2024.According to the complainant, the line was repeatedly alarming for air.Pump then alarmed that "air accumulation maximum" had been reached.Champagne bubbles were tapped out.Line eventually needed to be cavi wiped and placed back in pump.The complaint device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.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.

• 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: 20734738
• Report Number: 2523676-2024-01039
• Device Sequence Number: 8297762
• Product Code: FPA
• UDI-Device Identifier: 04046964294594
• UDI-Public: (01)04046964294594(11)230106(17)251231(10)0061868575
• 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
• Report Date (Section B): 11/22/2024

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 Expiration Date: 12/31/2025
• Device Catalogue Number: 363420
• Device Lot Number: 0061868575
• Was Device Available for Evaluation?: No
• 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: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2023
• 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