MAUDE Adverse Event Report: Sistemas Medicos Alaris S.A de C.V. BD Alaris Pump Module SmartSite Infusion Set; Intravascular Administration Set

Catalog Number	2420-0007
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the bd alaris pump module smartsite infusion set had flow issues.The following information was provided by the initial reporter: the alleged patient incident was pump over infused.Please see the incident details provided from clinical staff in the nicu department below: nicu managers reported that nicu patient received excess dose of glucose.Timeframe of incident: (b)(6) 2026, 6pm (b)(6) 2026, 8am iv bag start volume: 200ml iv bag end volume: 76ml alaris pump flow rate: 4.2ml/hr.The manager also reported that they discarded the infusion tubing set that was attached to alaris pumps at the time of incident.Serial number of units involved: pcu sn (b)(6) lvp sn (b)(6).Was there patient harm or injury? yes (high glucose).If so, kindly provide the details of what happened (patient symptoms and/or abnormal lab results).Chemstrip 600, serum glucose 668.What was the additional medical intervention provided to the patient? d12.5 tpn stopped and d5w starter tpn hung.What was the patient's outcome? glucose came down and stabilized.What was the name of the medication/fluid that over infused? glucose.What was the intended volume to be infused (vtbi)? 4.2ml/hr.What was the total bag/bottle volume and concentration? d12.5w 200 mls in bag to start.Are there any other infusions currently running at the time of the event? caffeine 0.71 mls given iv bolus over 10 minutes at 06:22 (3.96ml/hr).If so, please list the fluids/medication (name and rate of infusion): ns flush 0.7ml over 10 minutes.How was the medication/fluid programmed into the pump? (ex.Interoperability/barcode scanning, manually using guardrails drug library, or manually using basic infusion): entered manually using guardrails drug library.Please provide the serial numbers of the involved alaris devices: kindly specify the serial number of the pump module that was involved in the over infusion event: pcu sn (b)(6, lvp sn (b)(6).What was the brand/manufacturer and model # of the tubing set? bd alaris ref# 2420-0007.
Additional Manufacturer Narrative
Device evaluation: no product or photo was returned by the customer.The customer complaint of flow issues - accuracy could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 2420-0007 because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.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 Pump Module SmartSite 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 ; +1(847)393-5694
• MDR Report Key: 50899357
• Report Number: 9616066-2026-02424
• Device Sequence Number: 10706233
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: (01)07613203021012
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K221327
• 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): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Catalogue Number: 2420-0007
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/25/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown