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

Catalog Number	10015861A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite pump infusion set had a bulge / balloon in silicone segment / pump segment.The following information was provided by the initial reporter: i am reporting an incident we experienced with a bd alaris pump infusion set ref (b)(4).We only used one tubing set.Unfortunately, we do not have the saved packaging to report the specific lot number.We have narrowed the lot down to either (10)25125451 or (10)25055230.Administration set attached to base solution bag and primed with base solution.Chemotherapy compounded appropriately.Dose delivered to nursing unit via team member hand-off.Nursing administered dose via appropriate alaris pump set up procedures.Several hours after administration initiated pump alarm sounded alerting nurse of rate flow error.Upon evaluation, the nurse discovered bulging below upper pump fitment in pump segment line.
Additional Manufacturer Narrative
Device evaluation: two photos were taken by the customer that verify the tubing ballooning in the silicone segment.There is a potential root cause for this issue that is related to clinical practice when loading the set into the pump.Please refer to the instructions for use (ifu) of the product.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.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• 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: 25381883
• Report Number: 9616066-2026-01454
• Device Sequence Number: 9196929
• Product Code: FPA
• UDI-Device Identifier: 10885403232626
• UDI-Public: (01)10885403232626(11)251215(17)281214(10)25125451
• 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: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: 10015861A
• 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: 05/14/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown