MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS PUMP MODULE SMARTSITE TEXIUM 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	12/20/2024
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 infusion set was leaking the following information was received by the initial reporter with the following verbatim.It was reported by customer that leaking alaris sets when nurses are giving an iv push of chemotherapy.
Event or Problem Description
No further information was provided.
Additional Manufacturer Narrative
It was reported by customer that leaking alaris sets when nurses are giving an iv push of chemotherapy.One sample of infusion set 24010-0007t and three photos of infusion set 24010-0007t infusion set was, along with an unidentified syringe with a texium connector, were submitted for quality evaluation.Two photos were of the infusion set and one photo was of the infusion set packaging.Visual inspection of the samples did not identify any damages or abnormalities in the infusion set assembly.The unidentified syringe with the texium connector attached was connected to a bd smartsite and tested for leakage.There were no issues identified with the texium and syringe submitted.Investigation of the infusion set photos show that there is leakage from between the male luer connector and the texium luer connection.The physical sample was then primed and a smartsite connected to the texium connector to allow for flow through the infusion set.After the fluid was allowed to flow through the infusion set, a small leak was noticed coming from the union location of the male luer connector and the white thread body of the texium connector.The customer complaint of leakage for infusion set 24010-0007t was confirmed by evaluation.Investigation has been forwarded to the manufacturing facility for root cause determination.After the investigation was completed it was determined that the possible root cause of the leakage between the male luer and texium connector could be related to the incorrect loctite application and incomplete torque between components by the assembler due to no follow-up procedure in the standard work instruction and some improvement opportunities with the description of the torque operation.Additionally, a leak test was not performed for the pieces reported on the complaint or the defective pieces were incorrectly segregated due to an omission by the assembler.A quality alert was performed on may 05th, 2025 by the quality engineer ¿ post market support and communicated by production supervisor to the involved personnel to inform this failure mode and reinforce following the operations described in the sws, and be sure to add enough loctite and complete torque to assemble male luer and texium.Additionally, the process was updated to carry out the 100% leak test in production line and segregate the defective material to only sent good product to customers.A device history record review for model 24010-0007t lot numbers 24045382, 24055598, and 24085240 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE TEXIUM 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: 21141651
• Report Number: 9616066-2025-00009
• Device Sequence Number: 15785389
• Product Code: FPA
• UDI-Device Identifier: 10885403271021
• UDI-Public: (01)10885403271021(11)240826(17)270826(10)24085240
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/28/2025

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: 24085240
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown