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

Catalog Number	11522558
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module smartsite infusion set was leaking the following information was received by the initial reporter with the following verbatim fyi that we have had two instances now of tubing leaking.One was with chemo and one with ivf.Below is a picture of where it is leaking, the part of the tubing that goes in the pump.
Additional Manufacturer Narrative
H3: if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported by customer that they had two instances now of tubing leaking.One was with chemo and one with ivf.It is leaking at the part of the tubing that goes in the pump.One photo of an infusion set was submitted by the customer for quality investigation.Evaluation of the photo shows fluid leaking out of the silicone pumping tubing.The customer complaint of leakage is confirmed.Due to a physical sample not being provided, a root cause for the failure could not be determined.A device history record review for model 11522558 lot number 24039231 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 18aug2023.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
Material # 11522558, batch # 23085448, 24025573.It was reported by customer that they had two instances now of tubing leaking.One was with chemo and one with ivf.It is leaking at the part of the tubing that goes in the pump.Verbatim: i don¿t have all the information and i will get more, but i am out tomorrow so i wanted to send a quick fyi that we have had two instances now of tubing leaking.One was with chemo and one with ivf.Below is a picture of where it is leaking, the part of the tubing that goes in the pump.Additional information: 1.As advised the ivf tubing with hole was interoffice mailed to (b)(6) on 8/23.Will that be reaching to our plant? once my risk management department is done with the sample, i can certainly send it.Please send a label for me to do so.2.Kindly provide the valid lot number for # (10)2402557.This lot number seems to be invalid.Lot # (10)24025573.

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20241647
• Report Number: 9616066-2024-01338
• Device Sequence Number: 8913145
• Product Code: FPA
• UDI-Device Identifier: 10885403232305
• UDI-Public: (01)10885403232305(11)230818(17)260818(10)23085448
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 01/15/2025

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 Expiration Date: 08/18/2026
• Device Catalogue Number: 11522558
• Device Lot Number: 23085448
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown