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	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
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 pump module smartsite low sorbing infusion set had foreign matter.The following information was received by the initial reporter with the following verbatim.It was reported by customer that they found a big particle on tubing prior to get this infuse to a patient.
Additional Manufacturer Narrative
It was reported that there was a big particle on the tubing.One sample was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.No particle was seen on the tubing.It is possible that the decon process inadvertently washed away the particle.One photo was taken by the customer that verifies the complaint and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the possible root cause could not be determined since only a photo was provided to confirm the foreign matter in silicone tubing, the photo is enough to confirm the failure; however, this is not enough to identify the possible root cause (it could not be confirmed if the particle is inside or outside of the tubing), and it could not be confirmed either that the contamination could occur in 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.

• 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: 21323673
• Report Number: 9616066-2025-00141
• Device Sequence Number: 12742110
• Product Code: FPA
• UDI-Device Identifier: 07613203015806
• UDI-Public: (01)07613203015806
• 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): 04/04/2025

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: 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: 01/14/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 04/07/2025
• 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