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	22000-B007T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/23/2025
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 pump module smartsite texium infusion set had leakage.The following information was provided by the initial reporter: leaked at the male luer, chemo was being administered.
Additional Manufacturer Narrative
It was reported by customer that a leaked at the male luer.Two samples were received for quality evaluation.Visual inspection was conducted and no damages or abnormalities were identified.The samples were then primed and connected to a bd sample infusion set in order to conduct a simulated infusion.The simulated infusion was conducted at a rate of 125 ml/hr for 1 hour.The connection between the texium and the y-site smartsite connection was monitored for leakage.There were no issues identified during the simulation.The customer complaint of leakage could not be verified.A root cause was not determined because the failure could not be replicated on the samples submitted.Although we could not confirm the reported failure, 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 could not be performed because the lot number is unknown.

• 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: 22577625
• Report Number: 9616066-2025-02111
• Device Sequence Number: 9785171
• Product Code: FPA
• UDI-Device Identifier: 10885403245022
• UDI-Public: (01)10885403245022
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

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: 22000-B007T
• Device Lot Number: UNKNOWN
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/29/2025
• 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