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

Catalog Number	363421
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
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
As reported by the user facility: brief inquiry description zosyn medication administered quickly.Detailed inquiry description pt received zosyn at 1100.5 rights were performed and iv pump was set to run for 30 minutes per order.Tubing was primed properly and connections were checked as per protocol.About 5 minutes after this i was called to bedside d/t the iv pump beeping/alarming.The alarm was reading "air in line".The pump and line were inspecting and there was air in the line but had not reached the pt.I then noticed the zosyn medication was empty even though the medication was set to run for 30 minutes.The pump read it had 40 ml left to infuse.The pt was disconnected from that line.The patient stated she felt fine and md notified.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Additional information: d9 device returned to manufacturer date.One (1) used, not contaminated, sample was received for evaluation.A visual evaluation along with a comparison against drawing was conducted.The set is assembled within internal specifications.The sample then underwent further testing for free flow.In order to replicate the scenario, the set was hooked to the infusion pump.No alarm nor flow issues occurred during the testing period.Based on the investigation results the reported defect is not confirmed due to the absence of any defect.Although a thorough investigation was conducted, no defect was found at the time of testing.Therefore, the exact root cause of this incident could not be determined.No further corrective/preventative action is warranted 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 DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer (Section G): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21734056
• Report Number: 2523676-2025-00314
• Device Sequence Number: 4007550
• Product Code: FPA
• UDI-Device Identifier: 04046964294617
• UDI-Public: (01)04046964294617
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 363421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 04/25/2025
• 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