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

Catalog Number	2000E CHINA
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It is reported, the intravenous infusion link positive pressure connector set had blockage.Additional information: initial connection was not smooth; blockage.Please confirm if there are any visible defects to the device i.E., cracks, flashes, kinks? none; communicated with the patient; pre-filled the connector in advance please confirm if the connecting product has a luer slip or luer lock connection? luer-lock connector please confirm whether the flow was completely or partially blocked? partial blockage please confirm what medication was being administered during the event? infusion has not yet started please confirm is there any patient harm? none.

• Brand Name: ALARIS SMARTSITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 25004842
• Report Number: 9616066-2026-01112
• Device Sequence Number: 9884818
• Product Code: FPA
• UDI-Device Identifier: 07613203011938
• UDI-Public: (01)07613203011938(10)25065233
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K223088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: 2000E CHINA
• Device Lot Number: 25065233
• 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: 04/16/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown