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

Catalog Number	2423-0007
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite pump infusion set was occluded the following information was received by the initial reporter with the following verbatim.It was reported by the customer that a fluid infusion at 75ml/hr.Night shift nurse (b)(6) responded to an ¿occlusion patient side¿ alert and ¿trouble shot¿ the occlusion.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported by the customer that the tubing was alerting "occlusion patient side." one sample and one photo was received for quality investigation.Visual inspection did not indicate any damages or abnormalities.The infusion set was then primed, and a simulated infusion was conducted at a rate of 75 ml/hr for 1 hour.There were no flow issues or fluid blockage identified.A photo of the issue was provided by the customer.A bubble is shown at the top of the pumping segment tubing.Although a bubble is identified in the upper pumping segment, flow issues cannot be confirmed because we could not replicate the issue with the provided sample.Reviewing the information provided by the customer, it was indicated that an occlusion was attempted to be cleared when the flow issues - fluid blockage was identified.By attempting to "clear," an occlusion in the infusion line during an infusion, without properly clamping off the infusion set, a bubble can form in the soft silicone tubing of the pumping segment to back pressure created during the fluid push, as shown in the photo provided by the customer.However, the root cause of the issue was not determined because the reported failure could not be replicated with the sample.A device history record review for model 2423-0007 lot number 25085441 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No further information was provided.

• Brand Name: ALARIS SMARTSITE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23824380
• Report Number: 9616066-2025-03802
• Device Sequence Number: 12010226
• Product Code: FPA
• UDI-Device Identifier: 07613203020985
• UDI-Public: (01)07613203020985(10)2423-0007
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: 2423-0007
• Device Lot Number: 25085441
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown