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

Catalog Number	24010-0007T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite texium pump infusion set had leakage.The following information was provided by the initial reporter: i would like to report several instances of leakage from the smartsite access port of the alaris pump infusion set with the texium closed male luer connector (24010-0007t).A slow stream of chemotherapy drug was observed leaking from the access port when connected to a bag of fluid (saline solution or d5w) primary line.As the chemotherapy drug had been properly spiked and circle-primed without issue, we ruled out the drug preparation and the secondary line as potential sources of the issue.Our attention then turned to the primary infusion set, specifically the smartsite, which we suspected might be contributing to the leakage at the smartsite access port.To troubleshoot, we replaced the primary infusion set with a new one while keeping the same drug bag and secondary setup in place.After the replacement, the leakage ceased completely, confirming that the issue originated from the original primary infusion set.My concern is that the defective smartsite is not consistently tied to all products from the same lot number.For instance, we were able to resolve the leakage issue by switching to a new infusion set that shared the same lot number, indicating variability within the batch.This issue has been occurring too frequently and poses serious safety risk for our staff handling hazardous chemotherapy agents.In all cases, when the primed chemo secondary short set (the texium end) was connected to the primary set smartsite access port, a slow stream of fluid emerged from the smartsite port.The only successful remedy to date has been replacing both the primary line and the access port.Due to spillage and chemo loss, preparation of chemotherapy drugs sometimes needed to be repeated, adding to workload and resource use.Fortunately, no patient harm has occurred.The most serious near-miss involved chemotherapy spilling onto a patient's clothing.However, nurses preparing these infusions remain constantly at risk of exposure to chemotherapy agents during these incidents.
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 TEXIUM PUMP INFUSION 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: 23794936
• Report Number: 9616066-2025-03764
• Device Sequence Number: 20261860
• Product Code: FPA
• UDI-Device Identifier: 10885403271021
• UDI-Public: (01)10885403271021(17)280609(10)25065227
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 12/24/2025

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: Other
• Device Catalogue Number: 24010-0007T
• Device Lot Number: 25065227
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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