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

Catalog Number	24601-B007T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
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 pump module smartsite texium low sorbing infusion set was leaking.The following information was received by the initial reporter with the following verbatim.It was reported by customer that the leaking was due to this luer lock connection between texium tip and tubing.
Additional Manufacturer Narrative
One sample of material number 24601-b007t, lot number 24115483 was received for quality evaluation.Visual examination was conducted and no damages or abnormalities were identified.The sample was then primed with a sample bd smartsite connector connected to the texium connector.A simulated infusion was conducted at a rate of 125 ml/hr for 1 hour and there were not indications of leakage, air-in-line or occlusion.The customer complaint of leakage could not be verified.A root cause for the reported failure was not determined because the failure was not replicated.A device history record review for model 24601-b007t lot number 24115483 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 PUMP MODULE SMARTSITE TEXIUM LOW SORBING 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: 21936956
• Report Number: 9616066-2025-01063
• Device Sequence Number: 18138870
• Product Code: FPA
• UDI-Device Identifier: 10885403240959
• UDI-Public: (01)10885403240959
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/14/2025

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: 24601-B007T
• Device Lot Number: 24115483
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown