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	10/28/2024
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 customer stated that they we just had another leak.
Additional Manufacturer Narrative
It was reported that there was a leak at the point where the texium meets the tubing.Two samples model 10013361t, lot 24075224 were returned for investigation.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with water and no leaks were observed.An air under water pressure test was performed at 30 psi for 10 minutes.No leak was observed.Even though the issue was not able to be replicated actions have been initiated to investigate this failure mode.A device history record review for model 10013361t lot number 24075224 was performed.The search showed that a total of (b)(4) 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.
Event or Problem Description
Material#: 10013361t batch#: 24075224.It was reported by the customer that customer stated that they we just had another leak.Verbatim: customer stated that they we just had another leak.

• 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: 20787073
• Report Number: 9616066-2024-01732
• Device Sequence Number: 15201115
• 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): 02/05/2025

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: 10013361T
• Device Lot Number: 24075224
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 02/06/2025
• 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