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

Catalog Number	10015012
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
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 burette infusion set was leaking the following information was received by the initial reporter with the following verbatim.It was reported by customer that they noted leak where the tubing joins the buretrol.
Additional Manufacturer Narrative
It was reported by customer that they noted leak where the tubing joins the buretrol.One sample was received for quality evaluation.Visual inspection of the sample shows that the tubing was damaged and separated at the bottom of the drip chamber.Further evaluation of the sample indicates that the tubing may have been kinked prior to the tubing being damaged and leaking.Coil and packaging of the infusion sets before allowing the bonding solvent to dry completed can cause kinks to form in the tubing, making it easy to tear the tubing and break as seen in the sample provided.The customer complaint of leakage was confirmed.Further investigation was conducted at the manufacturing facility.After the investigation along with manufacturing and quality operations team, the most potential root cause that generates the leakage in the tubing/bottom cap burette was a separation/tubing degradation in engagement due an excess of solvent applied to the engagement by the production personnel.The lot reported was manufactured in december 2023, before improvements were implemented in the manufacturing process related to the solvent dispensers to help the production personnel in the insertion of the tubing to the solvent dispenser for solvent application.A quality alert was performed and communicated by the production supervisor to the involved personnel to inform them of this failure mode and reinforce following the operations described in the procedure and be sure to add the correct quantity of solvent to assemble tubing and drip chamber.A device history record review for model 10015012 lot number 23125110 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 04dec2023.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.
Event or Problem Description
No additional information was provided.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE BURETTE 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: 20571253
• Report Number: 9616066-2024-01577
• Device Sequence Number: 8827582
• Product Code: FPA
• UDI-Device Identifier: 10885403233951
• UDI-Public: (01)10885403233951(11)231204(17)261204(10)23125110
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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: 10015012
• Device Lot Number: 23125110
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown