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

Catalog Number	11171447
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite pump infusion set was leaking the following information was received by the initial reporter with the following.It was reported by customer that chemo found dripping from connection in the iv tubing.Able to resecure and continue the infusion.The second event the next morning at 0800.With this medication, air bubbles are very common, so they often have to remove the tubing from the pump and flick it to move the bubbles up.
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
Additional data: b7, d9, h3.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No additional information was provided.

• 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: 22435391
• Report Number: 9616066-2025-01859
• Device Sequence Number: 17291371
• Product Code: FPA
• UDI-Device Identifier: 07613203021234
• UDI-Public: (01)07613203021234(17)271203(10)24125051
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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: 11171447
• Device Lot Number: 24125051
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male