MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS PUMP MODULE SMARTSITE TEXIUM; 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	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with 2 bd alaris pump module smartsite texium leakage occurred at y-site where iv tubing is attached.There was no report of patient impact.The following information was provided by the initial reporter: iv tubing air leakage at lowest y-site (closest to patient) when additional iv tubing attached.Tubing replaced twice and air leakage occurred at the same location each time.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary the customer reported air leakage at the y-port, and returned one unopened sample.The sample was primed with water, but no leaks were found.The set was capped, pressurized with syringe, and still no leak of water or air was found.The complaint could not be verified.Without an observed failure, the root cause is unknown.Device history record review for model 24601-b007t lot number 22105077 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
It was reported that during use with 2 bd alaris pump module smartsite texium leakage occurred at y-site where iv tubing is attached.There was no report of patient impact.The following information was provided by the initial reporter: iv tubing air leakage at lowest y-site (closest to patient) when additional iv tubing attached.Tubing replaced twice and air leakage occurred at the same location each time.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE TEXIUM
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16519076
• Report Number: 9616066-2023-00387
• Device Sequence Number: 3290484
• Product Code: FPA
• UDI-Device Identifier: 10885403240959
• UDI-Public: 10885403240959
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2023

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: 10/06/2025
• Device Catalogue Number: 24601-B007T
• Device Lot Number: 22105077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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