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

Catalog Number	10813621
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2026
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 verbatim it was reported by the customer that 04/19 while doing my safety checks before starting cares, they noticed fluid on the floor underneath the bed, and it was very stickylike tpn.They saw it dripping from the end of the bed.After tracing my lines, they found drops on the iv tubing and around the junction where the med port on the iv pump infusion set is located.They showed action rn a.Xxxxx and notified the nnp a.Xxxxx.Grabbed a blood glucose which was 90 and the nnp ordered new fluids to hang.They placed a sticker where they noticed the leaking occurring on to the tubing extension set.
Additional Manufacturer Narrative
One bd primary set and one bd extension set was returned for investigation.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were primed with water and a leak was observed coming from the filter vent.Additional air under water test was performed.The set was pressurized with about 10psi and the vent was submerged under water.There was a steady stream of air bubbles coming from the filter vent.This would indicate that there is no issue with damage/ holes in the membrane.The reason for the membrane leaking is that the hydrophobicity of the membrane must have been compromised during use and not during the manufacturing process.

• 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: 25144070
• Report Number: 9616066-2026-01247
• Device Sequence Number: 9543458
• Product Code: FPA
• UDI-Device Identifier: 10885403234514
• UDI-Public: (01)10885403234514
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 05/13/2026

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: 10813621
• 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: 04/22/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown