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

Catalog Number	10012866
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
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 extension set was damaged the following information was received by the initial reporter with the following verbatim.It was reported by customer that there was blood backed up into tpn line, all the way to the tpn filter.I also noticed the filter itself was sticky to the touch around the 2 white circles on the flat side of the filter, which tpn is very sticky when spilled so this almost certainly is tpn leaking.There were no wet spots in the patient¿s bed, or on the floor of fluid leaking.I called the cn to look at the line, and she agreed that i should change the filter, flush the trifuse, and restart the tpn.I did so, and the line flushed perfectly so i attached a new filter to the tpn line and restarted the infusion.I had given another iv medication at ~0300, and the line had looked like normal.So, the filter failed in between 0300 and 0400.This makes me think the filter was faulty because it was leaking tpn.
Additional Manufacturer Narrative
Investigation summary: one sample was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was flushed with water and a leak was observed coming from both vents of the filter.The set was laid out to dry and an air under water pressure test was performed.The hydrophobicity of both vents was restored.The likely cause of the leakage was the drug used in the set caused the membranes to lose their hydrophobicity properties.
Event or Problem Description
No additional information.

• Brand Name: BD ALARIS SMARTSITE EXTENSION 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: 24281743
• Report Number: 9616066-2026-00241
• Device Sequence Number: 15903450
• Product Code: FPA
• UDI-Device Identifier: 10885403233777
• UDI-Public: (01)10885403233777
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 03/25/2026

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: 10012866
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/11/2026
• 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