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

Catalog Number	2432-0007
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite pump infusion set was damaged.The following information was provided by the initial reporter: in discussion with a bedside nurse, she stated that a "few filters had holes and leaked".Per the nurse, these instances occurred a few months ago and have not occurred since.It was only noticed when she was priming a drug or fluid and did not ever leak when they were connected to a patient.She specifically remembers she was priming and antibiotic and all of a sudden her whole hand was wet.Had to discard tubing.Stated that the tubing was the "normal tubing with inline filter" bd alaris pump infusion set 0.2 micron filter.Ref: 2432-0007 the icu manager has been unable to order iv pump tubing without smart sites.This is why the staff has been using the iv pump infusion set with smart sites for narcotics.The date this happened according to the information displayed on this tab from pharmacy jan 4, 2026 the date of knowledge is march 24, 2026.According to the information provided by pharmacy, there was a fentanyl waste discrepancy of 122mls.Patient involvement, issue was not found in real time but found multiple days after infusions started.The date this happened according to the information displayed on this tab from pharmacy jan 9, 2026 the date of knowledge is march 24, 2026.According to the information provided by pharmacy there was a fentanyl waste discrepancy of 65mls.Patient involvement, issue was not found in real time but found multiple days after infusions started.
Additional Manufacturer Narrative
B.3.The date of event is unknown; bd awareness date used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation summary: due to no sample being received, an investigation could not be performed, and a root cause could not be determined.No product will be returned per customer.No investigation was performed.

• 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.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24899356
• Report Number: 9616066-2026-00997
• Device Sequence Number: 18564527
• Product Code: FPA
• UDI-Device Identifier: 10885403232329
• UDI-Public: (01)10885403232329
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 2432-0007
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 04/22/2026
• 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