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

Catalog Number	24601-B007T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module smartsite texium low sorbing infusion set was leaking.The following information was received by the initial reporter with the following verbatim.It was reported by the customer that we have experienced multiple occurrences of leakage from the tubing, which has not only compromised the integrity of our chemotherapy protocols but has also posed significant safety risks to our staff and patients.Specifically, we have documented four instances where leakage occurred during chemotherapy infusions, necessitating the activation of our hazardous materials team to clean contaminated areas.This process is not only disruptive but also increases the potential for exposure to hazardous substances, which is unacceptable in a clinical setting.Additionally, we encountered a critical incident where the texium adapter broke while a nurse was attempting to attach it to a patient's iv port.This situation not only delayed treatment but also put the patient at risk and caused considerable distress among our staff.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Awareness date updated to 10/17/2024.
Event or Problem Description
Awareness date correction.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
The customer returned a video of the texium leaking at the connection site to a needle.The report of leakage was confirmed by the video.The issue was unable to be replicated for this complaint without a physical sample.However, there has been an increase of texium leakage complaints, and a large project was undertaken in our utah manufacturing facility, where texium is made.A trend has been identified, and actions have been initiated to investigate the issue.Corrective actions taken during this investigation will be implemented in our production process to further increase the robustness and reliability of the device and prevent future occurrences of this type.Device history record review for model 24601-b007t lot number 24066655 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 24jun2024.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 PUMP MODULE SMARTSITE TEXIUM LOW SORBING 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20709199
• Report Number: 9616066-2024-01672
• Device Sequence Number: 12814788
• Product Code: FPA
• UDI-Device Identifier: 10885403240959
• UDI-Public: (01)10885403240959(11)240624(17)270624(10)24066655
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2025

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: 24601-B007T
• Device Lot Number: 24066655
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 10/17/2024; 03/06/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 11/20/2024; 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown