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	06/24/2025
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 the bd alaris smartsite texium pump infusion set had leakage.The following information was provided by the initial reporter: we have had multiple lines of tubing from the same lot number start leaking during the infusion.The lot number is (10)25045192.It seems to be leaking from the texium green cap at the end.Additional information received from the customer: 1.Could you please provide exact number of occurrences? 5 2.Please let us know the medication being administered and leaked? was it a chemotherapy drug? ivf at bolus rate and premeds (dex and pepcid) 3.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No patient was harmed or injury.Only time and product replacement.
Additional Manufacturer Narrative
Four samples were received for quality evaluation.Visual inspection did not indicate any damages or abnormalities.The infusion sets were then primed and the texium connector was connected to a sample bd smartsite connector.While allowing fluid to flow through the set, leakage can be seen coming from between the smartsite connector to texium connection.The customer complaint of leakage was confirmed.A trend has been identified, and actions have been initiated to investigate the issue.Corrective actions taken during this investigation will be implemented in our production process to further increase the robustness and reliability of the device and prevent future occurrences of this type.A device history record review for model 24010-0007t lot number 25045192 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• 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.; 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: 22571707
• Report Number: 9616066-2025-02107
• Device Sequence Number: 21244436
• Product Code: FPA
• UDI-Device Identifier: 10885403271021
• UDI-Public: (01)10885403271021(10)25045192
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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: 25045192
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/25/2025
• 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