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

Catalog Number	2465-0007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris pump module smartsite low sorbing infusion set was leaking.The following information was received by the initial reporter with the following verbatim: it was reported by customer that leaking tubing/broken tubing.
Event or Problem Description
Material #:2465-0007.Batch#: 24055589.It was reported by customer that leaking tubing/broken tubing.Verbatim: complaint received via email(s) attached.Leaking tubing/broken tubing.
Additional Manufacturer Narrative
It was reported by customer that leaking tubing/broken tubing.One sample was submitted for quality evaluation.Visual examination was conducted and it can be seen that the sample separated at the upper pumping segment fitting.The customer complaint can be attributed to the silicone tubing separating from the upper pumping segment.The customer complaint of leakage was confirmed.There were no physical damages on the silicone tubing or the upper pumping segment.The customer also stated that the infusion set was leaking, indicating that they were able to prime the infusion set before the leakage was realized.The probable root cause for the failure is a mishandling or misloading of the infusion set.A device history record review for model 2465-0007 lot number 24055589 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20844512
• Report Number: 9616066-2024-01837
• Device Sequence Number: 8255924
• Product Code: FPA
• UDI-Device Identifier: 10885403221941
• UDI-Public: (01)10885403221941(11)240527(17)270527(10)24055589
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 01/14/2025

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: 2465-0007
• Device Lot Number: 24055589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown