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	10013361T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
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 we¿ve had two instances of leaking today from the point where the texium connector is attached to the tubing line.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation results: it was reported that the samples were leaking.Two samples model 10013361t, lot 24075224 were returned under (b)(4) for investigation but below to this complaint.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were flushed with water and pressure was applied using a bd 30 ml syringe filled with water.No leak was observed.The texium connector was tested with an air under water pressure test with up to about 30 psi.No leaks were observed.The customer complaint was unable to be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model 10013361t lot number 24075224 was performed.The search showed that a total of (b)(6) units in 1 lot number was built on 26jul2024.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.
Event or Problem Description
No additional information.

• 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: 20540990
• Report Number: 9616066-2024-01552
• Device Sequence Number: 20887790
• Product Code: FPA
• UDI-Device Identifier: 10885403223204
• UDI-Public: (01)10885403223204(11)240726(17)270726(10)24075224
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 10013361T
• Device Lot Number: 24075224
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 10/27/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown