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

Catalog Number	2426-0500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module smartsite infusion set was leaking the following information was received by the initial reporter with the following verbatim: it was reported by customer that the leaking occurs at the connection site between the texium secondary infusion set and the uppermost alaris primary infusion set y-site.The leak consists of a small amount of droplets forming during the infusion.It has occurred from the point of 30 minutes into the infusion to 45-95 minutes of an infusion.There is no commonality of base or drug solutions causing the leak.It has occurred a total of 5 times in the last 6 business days.Our facility uses alaris pumps which are currently maintained.
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
The customer reported the primary and secondary tubings are leaking at the texium-ysite connection and returned 4 samples of primary tubing 2426-0500, lots 24083012, 24073140, 24083015, and 24073135.Upon initial visual examination, the sets had no defects or abnormalities.The sets were tested along with the 3 samples of secondary tubing material (b)(6).No issues were observed during a gravity fed water infusion.Although we could not confirm the reported failure, a trend has been identified and actions have been initiated to investigate the texium leakage 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 was performed on all 6 lot numbers returned.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 #:(b)(4).Batch#:1024083015, 1024083012, 1024073140, 1024073135, 1024063259, and 1024093001.It was reported by customer that the leaking occurs at the connection site between the texium secondary infusion set and the uppermost alaris primary infusion set y-site.The leak consists of a small amount of droplets forming during the infusion.It has occurred from the point of 30 minutes into the infusion to 45-95 minutes of an infusion.There is no commonality of base or drug solutions causing the leak.It has occurred a total of 5 times in the last 6 business days.Our facility uses alaris pumps which are currently maintained.Verbatim: (b)(6) received a complaint via email.I have included a list of suspected lot numbers associated with the problem.The leaking occurs at the connection site between the texium secondary infusion set and the uppermost alaris primary infusion set y-site.The leak consists of a small amount of droplets forming during the infusion.It has occurred from the point of 30 minutes into the infusion to 45-95 minutes of an infusion.There is no commonality of base or drug solutions causing the leak.It has occurred a total of 5 times in the last 6 business days.Our facility uses alaris pumps which are currently maintained.Affected products * bd alaris pump infusion set * item number * 2426-0500.* suspected lots * 1024083015.* 1024083012.* 1024073140.* 1024073135.* 1024063259.Additional information: including (b)(6) supply chain manager (b)(6).(b)(6), below is the complete list of affected reference numbers and lots.The items in red text were involved in a spill today, (b)(6) 2024.* bd secondary infusion set: * item number * (b)(4).* suspected lots * (10)24079174.* (10)24089058.* (10)24059150.* bd alaris pump infusion set * item number * (b)(4).* suspected lots * 1024083015.* 1024083012.* 1024073140.* 1024073135.* 1024063259.* 1024093001.* item number * (b)(4).* suspected lots * 1024075224.Additional information: patient 1: 2 occurences 7 days apart: date of events: (b)(6) 2024.Patient 2: date of event: (b)(6) 2024.Patient 3: date of event: (b)(6) 2024.Patient 4: date of event: (b)(6) 2024.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE 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: 20674031
• Report Number: 9616066-2024-01643
• Device Sequence Number: 18366107
• Product Code: FPA
• UDI-Device Identifier: 07613203020992
• UDI-Public: (01)07613203020992(11)240801(17)270801(10)24083015
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/06/2025

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: 2426-0500
• Device Lot Number: 24083012
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown