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

Catalog Number	24301-0007T
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	08/06/2025
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 smartsite texium pump infusion set was damaged the following information was received by the initial reporter with the following verbaitm it was reported by the customer that there was a pinhole in the tubing that caused it to squirt out of the tubing and all over her shirt when she went to administer it.
Additional Manufacturer Narrative
One sample was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with water and a leak was coming from a pinhole at the bottom of the silicone segment.The customer complaint was verified.From the manufacturer's investigation, it was not possible to identify a potential root cause that is related to the manufacturing process.However, pumping segment improvements have been implemented to improve the robustness of the assembly process.Updates to the procedures are in process.A device history record review could not be performed on material 24301-0007t because the lot number is unknown.

• 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: 22936040
• Report Number: 9616066-2025-02610
• Device Sequence Number: 9919565
• Product Code: FPA
• UDI-Device Identifier: 10885403223198
• UDI-Public: (01)10885403223198
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2025

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: 24301-0007T
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/15/2025
• 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