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

Catalog Number	11426965
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module smartsite infusion set had air bubbles in the tubing at the connection site below the pump.The following information was provided by the initial reporter: event details: ¿while giving routine medications, i was about to connect a short set to the patients main fluid line.While tracing the line, i noticed a significant amount of air in the tubing below the pump.I also noticed air bubbles appearing just after one of the connecting sites.¿.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
No additional information was provided mat#: 11426965 lot#:23015088 it was reported by customer that while giving routine medications, customer was about to connect a short set to the patients main fluid line.While tracing the line, customer noticed a significant amount of air in the tubing below the pump.Customer also noticed air bubbles appearing just after one of the connecting sites.Verbatim: air bubbles in tubing and connection site hello bd team, good afternoon.On 08/26/2023, we had a safety event reported for bd item # 11426965 (bd alaris pump infusion set: bd alaris¿ lvp 20d cv).Let¿s identify this as bd 247, as a reference number.The defective product is available for pick up from defect depot.Please contact xxxxxxx (copied here) for any defect depot related questions.Based on the information provided below, could you start a product quality report? bd 247: reported date: 08/26/2023; event date: 08/26/2023; item number: 11426965; lot number: 23015088; item retained in defect depot?: yes; picture: yes, attached; patient harm: no harm; area: g9 ((b)(6) hospital) event details: ¿while giving routine medications, i was about to connect a short set to the patients main fluid line.While tracing the line, i noticed a significant amount of air in the tubing below the pump.I also noticed air bubbles appearing just after one of the connecting sites.¿ thanks, xxxxx.
Additional Manufacturer Narrative
It was reported by customer that while giving routine medications, customer was about to connect a short set to the patients main fluid line.While tracing the line, customer noticed a significant amount of air in the tubing below the pump.Customer also noticed air bubbles appearing just after one of the connecting sites.One sample of material number 11426965, and an unknown non-bd secondary set was submitted for quality evaluation.The customer complaint of air in line was confirmed during investigation.The sample of material 11426965 was examined for any visible damages or defects.During the visual inspection a smartsite y-site looked to be engaged without being connected to a corresponding male luer.The infusion set was then primed with water, in order to determine if the valve was allowing air to get into the fluid line.As the water would move past the smartsite y-site, air bubbles would form in the fluid line and water would also leak from the same opening.The cause for the air in line in the infusion set is a y-site smartsite valve being stuck open.The manufacturing location was informed of the issue and an investigation was conducted at the manufacturing site.Evaluation of the manufacturing process did not replicate the failure seen in the smartsite.The smartsite was then flushed with water and retested for functionality.After flushing the smartsite, the component worked as intended.The root cause for the failure of the component could not be determined.Based on previous smartsite investigations, an excess amount of fluorosilicone used in the construction of the smartsite can cause issues with the valve staying open, however, excessive solvent was not observed in the sample.A quality alert had been issued to the assembly personnel, and additional fixtures had been added to the assembly procedure, to address fluorosilicone issues.A device history record review for model 11426965 lot number 23015088 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10jan2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The cause for the air in line in the infusion set is a y-site smartsite valve being stuck open.The manufacturing location was informed of the issue and an investigation will be conducted as to why the y-site is stuck open.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• 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.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17814739
• Report Number: 9616066-2023-01958
• Device Sequence Number: 6056520
• Product Code: FPA
• UDI-Device Identifier: 50885403232556
• UDI-Public: (01)50885403232556
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2024

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: Health Professional
• Device Expiration Date: 01/10/2026
• Device Catalogue Number: 11426965
• Device Lot Number: 23015088
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown