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

Model Number	2465-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
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
It was reported while using bd alaris pump module smartsite low sorbing infusion set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: bd alaris pump infusion set smartsite bag access non-vented 0.2 micron filter low sorbing tubing (ref 2465-0007) lot number (10)21116110) the infusion set was infusing a chemotherapy drug for ~20 hours when we noticed that on the back of the filter there was some fluid outside of the tubing set.
Additional Manufacturer Narrative
H6: investigation summary one photo was received with the customer's complaint of leakage.The photo shows the filter air vents on set circled and is sufficient to verify the leakage.Without a sample for further investigation, the root cause of this failure is unknown.A device history record review for model 2465-0007 lot number 22115367 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.
Event or Problem Description
It was reported while using bd alaris pump module smartsite low sorbing infusion set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: bd alaris pump infusion set smartsite bag access non-vented 0.2 micron filter low sorbing tubing (ref 2465-0007) lot number (10)21116110) the infusion set was infusing a chemotherapy drug for ~20 hours when we noticed that on the back of the filter there was some fluid outside of the tubing set.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16773077
• Report Number: 9616066-2023-00729
• Device Sequence Number: 14237939
• Product Code: FPA
• UDI-Device Identifier: 50885403221949
• UDI-Public: (01)50885403221949
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/25/2023

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: 11/15/2025
• Device Model Number: 2465-0007
• Device Catalogue Number: 2465-0007
• Device Lot Number: 22115367
• 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: 03/29/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• 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