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

Catalog Number	2426-0007
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris pump module smartsite infusion set was occluded.The following information was provided by the initial reporter: when running pitocin with the main line fluids, we have to turn the rate of the main line way down, or it will beep occlusion on the pt side of the pitocin line.We are having to turn our maintenance fluids down very low to get the pitocin to run.Has there been any patient harm? no instances of patient harm reported.It is the potential for patient harm that concerns the staff.Please give a detailed description of the event.For induction of labor, the oxytocin administration starts with 2 ml/hr and a maintenance fluid of 50 ml/hr.Bd alaris pumps begin to alarm for pressure, and the oxytocin will stop running (alarms ¿occluded on patient side.¿).The maintenance fluids must be decreased to 25 ml/hr to get oxytocin running again.If the patient elects to have an epidural, the maintenance fluid needs to be increased to help prevent hypotension, but this can be a challenge if the oxytocin continues to alarm ¿occluded on patient side.¿ list all interventions provided to the patient.None.It is an equipment issue.Please list the serial numbers of all involved alaris devices.Bd alaris pumps in general.What are the current occlusion alarm settings? the current occlusion alarm settings are set to 525 mmhg.Is it noted with one type of medication (ex pitocin) or regardless of medication running? yes, the oxytocin administration is an issue.
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.

• 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: 50806111
• Report Number: 9616066-2026-02340
• Device Sequence Number: 10589813
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: (01)10885403227998(17)290527(10)26053289
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 09/21/2026

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: 2426-0007
• Device Lot Number: 26053289
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Supplement Date Received by Manufacturer: 09/20/2026
• Initial Report FDA Received Date: 09/17/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown