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

Catalog Number	490105
Medical Device Problem Code	Device Alarm System (1012)
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: details of complaint (reported issue): "halfway through the transfusion, pump kept indicating "air in line".All methods of troubleshooting applied to no avail.When using a blood warmer, there is approximately 50cc of blood in the tubing.Without being able to resolve the false "air in line" message (there was no air visualized in the line when i removed it from the pump and inspected it), we are going to waste, at minimum, 50cc of blood.In order to salvage some of the blood, i manually squeezed the saline back to try to push blood down the line to the point of the connection of the iv tubing to the blood warmer tubing.At this point, we had to get a new blood tubing to replace the one indicating false air in line.Thankfully blood bags have two available ports to spike, if they did not, we would have had to have thrown out the entire remaining unit of blood because the first spike cannot be removed (i tried).So now, we have one "faulty" tubing line hanging from the blood bag while the new line is used to complete the infusion.At the very least, the patient did get the remainder of the unit of blood and no harm was done.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer Contact: elena reifenstein ; 824 12th ave; bethlehem, PA 18018 ; 8334251464
• MDR Report Key: 25267014
• Report Number: 2521402-2026-00547
• Device Sequence Number: 13187702
• Product Code: FPA
• UDI-Device Identifier: 04046964186165
• UDI-Public: (01)04046964186165(11)251114(17)281031(10)0062029313
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: 490105
• Device Lot Number: 0062029313
• 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: 05/07/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/24/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2025
• 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