MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. BD ALARIS SMARTSITE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20027E
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite extension set had an occlusion.The following information was provided by the initial reporter: while on-site today i received a complaint from a nurse who was delivering phenytoin 500mg/110ml @ 220ml/hr via lvp.The rn primed the 3 port dedicated set with a 0.2 micron filter attached to the end, the filter stopped priming when it got to the actual filter and would not go any further so, the nurse loaded the set into the lvp and programmed it accordingly to have more pressure to prime to the end of the filter line.The nurse stated that there was immediate occlusion alarms when the set was loaded and started, prior to attaching to patient.Once the fluid reached the end of the filter line, the rn attached to the patient and resumed the infusion.She stated that there were continuous occlusion alarms throughout the infusion ¿ so much so that the infusion took 30 minutes longer than it was intended to.The nurse reported no issues with the access itself, no issues flushing, etc.The medication was not reported as a viscous solution.Ref: (b)(4).Lot: (10)25125179.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: due to no sample being received, an investigation could not be performed, and a root cause could not be determined.No product will be returned per customer.No investigation was performed.

• Brand Name: BD ALARIS SMARTSITE EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24587272
• Report Number: 9616066-2026-00643
• Device Sequence Number: 14868284
• Product Code: FPA
• UDI-Device Identifier: 10885403234859
• UDI-Public: (01)10885403234859(11)251204(17)281203(10)(10)25125179
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: Other
• Device Catalogue Number: 20027E
• Device Lot Number: (10)25125179
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown