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

Catalog Number	10802688
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite pump infusion set was separated the following information was received by the initial reporter with the following verbatim it was reported by customer that when connecting secondary abx iv tubing to primary ns tubing and opening clamps, secondary tubing suddenly disconnected at y-site.Ns fluid was flowing out of broken tubing, this rn clamped both iv tubing and placed faulty supplies into bag.
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
One sample model 10802688 was returned for investigation.The set was examined for defects and abnormalities.The tubing was separated from the outlet port of the most distal y-site.No other defects or abnormalities were observed.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the failure mode (separation tubing/y-site) was addressed on (b)(6) 2025 for a similar incident, and the following actions were taken: - quality alert was created on (b)(6) 2025 to communicate the failure mode and reinforce the correct solvent application method and follow up to standard work instruction.- work order was created on (b)(6) 2025 to review the solvent dispenser.Sku reported on this complaint is not planned to be produced at hmo site, sku reactivated in tj site.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD ALARIS SMARTSITE 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: 22495668
• Report Number: 9616066-2025-01991
• Device Sequence Number: 8459023
• Product Code: FPA
• UDI-Device Identifier: 10885403234439
• UDI-Public: (01)10885403234439(10)25033132
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/04/2025

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: 10802688
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 11/07/2025
• 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