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

Catalog Number	10012866
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
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 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 one of the picc fluid lines was leaking.Upon further inspection it was the large bore filter that was leaking from the filter itself.
Event or Problem Description
No additional information provided.
Additional Manufacturer Narrative
The customer reported the filter was leaking while infusing tpn, and returned one used sample of material 2477-0007, lot unknown.Customer returned sample using the fedex label (b)(4) created for (b)(4).Upon initial visual examination, the set had no defects or abnormalities.The set was infused with water, to flush the system.The supplier of the filter component suggests a bubble test, which consists of infusing air into the set while submerged underwater.This test is for the air vent membrane of the filter, which is the main culprit involved in the filter leaks.The bubble test showed that the filter was working properly, which shows the filter's air vent membrane hydrophobicity was compromised.The air vent can be compromised by the end user drugs/solutions used.The root cause for the filter issue is related to the end user drugs, in this case tpn, compromising the filter.A device history record review could not be performed because the lot number is unknown.

• 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: 23028062
• Report Number: 9616066-2025-02729
• Device Sequence Number: 13118628
• 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): 10/06/2025

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: 10012866
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/07/2025
• 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