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

Catalog Number	2202-0007
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: no product or photo was returned by the customer.The customer complaint of air bubbles / air in line could not be verified due to the product not being returned for failure investigation.A device history record review for material# 2202-0007 and lot# 23095114 was performed.The search showed that a total of 19,203 units in 1 lot number was built on 07sep2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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.
Event or Problem Description
It was reported that the bd alaris smartsite pump infusion set had air bubbles / air in line.The following information was provided by the initial reporter: when i got on shift and was getting report the iv running d 10 spn with heparin alarmed for air in the line.We didn't see any air and ran the line again.A few minutes later i noticed a 1.5-2 cm air bubble in the line.I ran the line to get rid of the bubble but it got caught in the filter.I had the charge nurse help me to clear the filter and we did but as we were allowing the end of the iv connecter fill up to re attach the fluids to the baby we noticed it was quickly back flowing into the filter chamber.We decided it was bad tubing and got new.We primed the line and made sure there was no air in the filter and connected to the baby.10 or so minutes later i was inspecting it again and noticed a large amount of air in the filter that had recently been full of fluid.We ran fluids through it again and it looked full of fluid.Everything looked good so we reattached the fluids to the baby.While feeding the baby 20 or so minutes later a 1 cm air bubble showed up between the baby and the filter.We looked at the lot number and all but one of the lines in the supply room were from the same lot.We pulled that lot and used the one other set of tubing and it is working fine.Mfg #: 2202-0007.Lot #: 23095114.Quantity affected: 2 ea.Was there injury? reached the individual but did not cause harm.

• 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: 25307145
• Report Number: 9616066-2026-01389
• Device Sequence Number: 9319275
• Product Code: FPA
• UDI-Device Identifier: 10885403274039
• UDI-Public: (01)10885403274039(11)230907(17)260907(10)23095114
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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 Expiration Date: 09/07/2026
• Device Catalogue Number: 2202-0007
• Device Lot Number: 23095114
• 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: 05/06/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown