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

Catalog Number	10802688
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 gravity set was leaking the following information was received by the initial reporter with the following verbatim.It was reported by customer that the tubing tends to "kink" once it is put back in the iv warmer.They had experienced two tubings that the blood went up to the first injection site and even exceeded.
Additional Manufacturer Narrative
One photo was taken by the customer that verifies the tubing kink.A quality notification was sent to the manufacturer.From the manufacturer's investigation, the potential root cause of kinked tubing between tubing and drip chamber could be related to issues with the solvent dispenser, incorrect solvent application, incorrect arraignment of the component inside the pouch or keep tube in the fixture by the assembler.The failure mode was addressed where the work standard instruction for the model 10802688 was updated on may 04th, 2023 to add the correct solvent dispenser.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
No additional info.

• Brand Name: ALARIS SMARTSITE
• 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: 22049104
• Report Number: 9616066-2025-01278
• Device Sequence Number: 9018188
• Product Code: FPA
• UDI-Device Identifier: 10885403234439
• UDI-Public: (01)10885403234439
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/10/2025

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: 10802688
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/15/2025
• 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