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

Catalog Number	10010454
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
We have had 4 instances of chemo leaking.On (b)(6) 2025 customer response: yesterday i had a conversation with our pharmacy staff and our op chemo department that the leak happened in.As we discussed i learned there were 2 or 3 other chemo leaks with the same tubing, on the same patient.It doesn't take a rocket scientist to figure out the patient must be doing something during their treatment, messing with the tubing, etc.To cause this to leak.I told them to monitor the patient on the next treatment.Based on all of this information i am pretty sure the tubing is fine and we are good here.Sorry for the fire drill and waste of your time.
Additional Manufacturer Narrative
The customer reported that chemo was leaking from the filter, and returned one used sample of material 2426-0007, lot 25045099.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 leakage is related to the end user drug used, in this case, chemo, compromising the filter.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
No additional information provided.

• Brand Name: ALARIS SMARTSITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 23038850
• Report Number: 9616066-2025-02751
• Device Sequence Number: 21201512
• Product Code: FPA
• UDI-Device Identifier: 07613203015806
• UDI-Public: (01)07613203015806(17)280502(10)25055037
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare 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: Health Professional
• Device Catalogue Number: 10010454
• Device Lot Number: 25055037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown