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

Catalog Number	2432-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
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
It was reported that bd alaris smartsite pump infusion set was leaking the following information was received by the initial reporter with the following verbatim.It was reported by a customer that after priming infusion set filter noted to be leaking fluid.
Additional Manufacturer Narrative
The customer reported that the set was leaking after priming, and returned one used sample of material 2432-0007, lot 25045563.Upon initial visual examination, the set had no defects or abnormalities.The complaint report of leaking at the filter was confirmed by the sample, the filter leaked at the air vent.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The supplier of the filter was contacted for further investigation.Their investigation of the sample found no issue with the manufacturing or quality of the filter.The filter may have issues, including leaks, when infusing certain medications that are high in alcohol content.The root cause cannot be defined.

• Brand Name: BD ALARIS SMARTSITE PUMP INFUSION SET
• 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: 23880411
• Report Number: 9616066-2025-03909
• Device Sequence Number: 4706886
• Product Code: FPA
• UDI-Device Identifier: 10885403232329
• UDI-Public: (01)10885403232329(17)280422(10)25045563
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/19/2026

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: 2432-0007
• Device Lot Number: 25045563
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown