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

Catalog Number	10010454
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 10010454 batch # 24085258.It was reported by customer that there were reports of leaks at the filter.Rcc received a complaint via email.There were reports of leaks at the filter.Pharmacy has several tubing sets on hand, and we quarantined them for safety reasons since we are administering chemotherapy and want to prevent any further leaks and hazardous drug spills.Customer response on (b)(6) 2025.Sorry for the delay.Patient care needs in infusion have delayed me in getting around to responding to emails.I am also in search of a box big enough to send back all of the remaining lot, so when i have that, i can send the shipment.I can try to email you when it goes out.Being that it is thursday with the weekend coming up, i suspect the earliest it will ship will be monday (b)(6)2025.1.Can you please provide an exact date of event in format mm-dd-yyyy? 01-08-2025 2.What was the drug being infused? paclitaxel.3.How long was the infusion going before the leak was observed? 8 minutes.4.What was the rate of infusion? 196.7 ml/hr.5.Was the leak coming from the vent of the filter? if not, can you describe where the leak was coming from on the filter? from what was observed, rn returned the bag with the leak coming from the inline filter piece.It is difficult to determine since solution is clear and so is the filter.It appears to originate from the small circle portion of the filter of the white piece.
Additional Manufacturer Narrative
A box of 150 unused samples model 10010454, lot 24085258 were returned for investigation.Evaluation of 59 samples were performed.The sample size quantity was determined per sample size selection work instruction.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were primed with water and infusion run was performed to simulate the customer's set-up.No leaks were observed.The customer complaint was unable to be replicated.Although the issue was not replicated, the possible reason for the membrane leaking is that the hydrophobicity of the membrane must have been compromised during use and not during the manufacturing process.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.
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 pump module smartsite low sorbing infusion set was leaking the following information was received by the initial reporter with the following verbatim.It was reported by customer that there were reports of leaks at the filter.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE LOW SORBING 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: 21413197
• Report Number: 9616066-2025-00287
• Device Sequence Number: 8235196
• Product Code: FPA
• UDI-Device Identifier: 07613203015806
• UDI-Public: (01)07613203015806(11)240826(17)270826(10)24085258
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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: 10010454
• Device Lot Number: 24085258
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown